Morris v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 12-415V
(TO BE PUBLISHED)

***********************
MATTHEW MORRIS, *
* Special Master Corcoran
Petitioner, *
* Dated: April 1, 2016
v. *
* Vaccine Act; Entitlement; Ruling on
SECRETARY OF HEALTH AND * Record; Tetanus-Diphtheria-acellular
HUMAN SERVICES, * Pertussis (“TDaP”) Vaccine;
* Fibromyalgia; Myalgias; Myositis.
Respondent. * Macrophagic Myofasciitis (“MMF”)
*
***********************

Patricia Finn, Patricia Finn, P.C., Piermont, NY, for Petitioner.

Alexis Babcock, U.S. Dep’t of Justice, Washington, DC, for Respondent.

DECISION1

In this case arising under the National Vaccine Injury Compensation Program (hereinafter
the “Vaccine Program”),2 Matthew Morris (“Petitioner”) seeks damages based on alleged injuries
caused by his receipt of the Tetanus-Diphtheria-acellular Pertussis (“TDaP”) vaccine on August
29, 2009. The parties have accepted my proposal to rule on the case based on the expert reports,
record evidence, and pleadings submitted to date. After consideration of the Parties’ arguments

1
Because this decision contains a reasoned explanation for my actions in this case, I will post it on the United States
Court of Federal Claims website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). As
provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the published decision’s inclusion of
certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within
which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or
financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure
of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole
decision will be available to the public. Id.

2
The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660,
100 Stat. 3758, codified as amended, 42 U.S.C. §§ 300aa-10 through 34 (2012) [hereinafter “Vaccine Act” or “the
Act”]. Individual section references hereafter will be to § 300aa of the Act.
and the evidence, I hereby DENY Petitioner’s claim, for the reasons discussed in greater detail
below.

I. FACTUAL BACKGROUND

Petitioner has offered various documents and medical records to support his claim. Pet’r’s
Exs. 1-10. It is undisputed that Mr. Morris received the TDaP vaccine on August 29, 2009, at Lake
District Hospital in Lakeview, Oregon, after puncturing his finger on rusty barbed wire. Pet’r’s
Ex. 7 at ¶3; Pet’r’s Ex. 2 at 1. At the time, Mr. Morris resided in rural Oregon and was without
income or health insurance. Pet’r’s Ex. 7 at ¶2.

Mr. Morris alleges that by September 5, 2009, he began to experience debilitating flu-like
symptoms, accompanied by aches, pains, and fever, that made it difficult for him to participate in
his normal activities. Pet’r’s Ex. 7 at ¶¶5-6. These flu-like symptoms allegedly intensified greatly
by the beginning of October of that year. Id. at ¶7. Petitioner began to experience numbness in his
hands and shooting bilateral pains in his arms and legs, all of which caused him great fatigue. Id.
at ¶¶9, 11-14. Although Petitioner claims to have continued to experience these symptoms through
the spring of 2010, his financial situation, lack of insurance, and a harsh, snowy winter (which
limited his ability to travel from his rural home) collectively caused him to postpone seeking
medical attention for his alleged illness for more than nine months. Id. at ¶¶10, 12. Instead, he self-
medicated with family prescription drugs during the intervening period. ECF No. 41 at 2.

Mr. Morris submitted several letters from his family and friends attesting to his
deterioration after receiving the TDaP vaccine, and explaining why he did not immediately seek
medical treatment. See generally, ECF No. 41. His parents wrote a letter, for example, averring
that it was a “time of turmoil and change for our family” because Mr. Morris’s father was also ill.
Id. at 6. The letters also state that Mr. Morris communicated to various third parties that “his bones
hurt” and he “felt sick.” Id. at 9, 12-17. But, according to his parents, they were “snowed in for
months” and it was “difficult to get in to town.” Id. at 6. Mr. Morris’s father corroborates
Petitioner’s statements that he was self-medicating with his family’s prescription pills. Id.

As the medical records reflect, it was not until May of 2010 that Mr. Morris visited his
family physician, Dr. Paul Johnson at the Johnson and Cade Family Practice in Bend, Oregon –
although the purpose of the visit was for removal of a skin lesion on his hip. Pet’r’s Ex. 1 at 4.
Nevertheless, Petitioner mentioned to Dr. Johnson at that time that he was experiencing ongoing
pain (which the record characterizes as “bone pain”) throughout his body, and that he associated
this pain with his August 2009 vaccination. Id. But Dr. Johnson’s physical examination revealed
normal joints, normal muscle strength, and normal tone. Id. Laboratory testing reported on May 7,

2
2010, were also normal, including Petitioner’s rheumatoid factor, ESR,3 CRP,4 CM,5 and complete
blood count. Id. at 10-11. The laboratory results also reported an ANA6 Titer of 1:80 with a
homogeneous pattern. Id. Despite the lack of corroborative lab results, because of Mr. Morris’s
complaints, Dr. Johnson recommended that he see a rheumatologist for evaluation and prescribed
Diclofenac, an anti-inflammatory drug. Id. at 2.7

Later, at a June 2010, follow-up visit with Dr. Johnson, Mr. Morris again complained of
the same significant pain throughout his body, although most notably in his left arm, asserting that
the drugs he was taking were not alleviating the pain. Pet’r’s Ex. 1 at 2. He repeated to Dr. Johnson
his belief that the TDaP vaccine was the source of his illness. Id. In July 2010, Mr. Morris next
visited Dr. Ronald Rosen (an integrative medicine specialist) in Bend, Oregon, who diagnosed him
with myalgias and paresthesias, although a physical exam performed at the time showed nothing
out of the ordinary. Pet’r’s Ex. 4 at 2. Dr. Rosen recommended a follow-up if Mr. Morris’s
condition did not improve within three weeks. Id. at 3.

Dr. Daniel Evan Fohrman, a rheumatologist with Deschutes Rheumatology in Bend,
Oregon, subsequently evaluated Mr. Morris for his reported musculoskeletal pain in September of
2010. Pet’r’s Ex. 3 at 1. On physical examination, Mr. Morris displayed no “synovitis, effusion,
deformity, laxity, or decreased range of motion,” and his muscle strength was not abnormal. Id. at
4. Dr. Fohrman therefore diagnosed Mr. Morris with musculoskeletal pain of unknown etiology
and recommended a trial of prednisone. Id. Dr. Fohrman also stated that he could “neither approve
nor disprove” Mr. Morris’s personal theory that the TDaP vaccine had caused his symptoms. Id.
Dr. Fohrman’s ultimate diagnosis of Mr. Morris was “fibromyalgia/myalgia/myositis.” Id. at 7.

3
ESR means erythrocyte sedimentation rate. Dorland’s Illustrated Medical Dictionary (32d ed. 2012) at 648
[hereinafter Dorland’s]. This is one of the factors that Dr. Oddis later characterizes as part of Mr. Morris’s
rheumatology work-up.

4
CRP means C-reactive protein. Dorland’s at 436. This is also one of the factors that Dr. Oddis later characterizes as
part of Mr. Morris’s rheumatology work-up.

5
CM means cytidine monophosphate. Dorland’s at 376. This is yet another one of the factors that Dr. Oddis later
characterizes as part of Mr. Morris’s rheumatology work-up.

6
ANA stands for antinuclear antibodies. Dorland’s at 70. An elevated ANA is usually an indication of an autoimmune
reaction. Pet’r’s Ex. 17 at 3. The value of 1:80 is slightly elevated, although (as discussed below) there is disagreement
between the parties and their experts as to the significance of this value. Resp’t’s Ex. A at 3 (ECF No. 53-1); Pet’r’s
Ex. 17 at 2 (ECF No. 57); Pet’r’s Br. on Entitlement at 3 (ECF No. 65) (“Opp.”).

7
Dr. Fohrman also prescribed Lamisil (an anti-fungal drug) to Mr. Morris at this visit, presumably for treatment of
his skin lesion. Pet’r’s Ex. 1 at 4.

3
 By November of 2010, Mr. Morris was still complaining of myalgias and joint pain,
asserting that the steroid treatment prescribed by Dr. Fohrman had not improved his condition.
Pet’r’s Ex. 1 at 1. Dr. Fohrman saw Petitioner at this time but did not do an examination (although
Petitioner once again reiterated his belief that there was a relationship between the vaccine he had
received and his symptoms). Id. Mr. Morris returned to see Dr. Johnson in May of 2011, again
complaining of chronic pain. Pet’r’s Ex. 9 at 1. Mr. Morris’s June 21, 2012, affidavit asserts that
(as of that date) the pain he had experienced since receiving the TDaP vaccination had not ceased
and responded only minimally to prescription pain medication. Pet’r’s Ex. 7 at ¶¶18-20. As a result,
he alleged that he could not work or live as a functioning independent adult, requiring him to rely
on the financial support of family members for medical costs and other basic needs. Id. at ¶20.

Mr. Morris has not filed any additional medical records since September of 2012, and has
filed no additional records relevant to the claim for the time period after his visit to Dr. Johnson in
May of 2011, so his current condition or prognosis is unclear. However, On October 27, 2014,
Petitioner filed a letter in this action further describing how his ailments were continuing to affect
him. ECF No. 41 at 1-4. He also submitted a letter from Dr. Spencer Clarke, his “regular Doctor”
as of 2014 who he had been seeing for the six-month period prior to the letter’s creation. Id. at 5.
In this letter, Dr. Clarke acknowledges that Mr. Morris’s physical exam and previous serologic
work up were fairly unremarkable, but nevertheless maintains the possibility of a relationship
between Mr. Morris’s pain complaints and his vaccination. Id.

II. EXPERT REPORTS

A. Dr. Beatrice C. Engstrand

Petitioner filed two reports from his expert, Dr. Beatrice C. Engstrand (on March 31, 2015,
and August 20, 2015, respectively) in support of his claim. Pet’r’s Ex. 11 (ECF No. 50-1); Pet’r’s
Ex. 17 (ECF No. 57-1). In preparing the reports, Dr. Engstrand reviewed Mr. Morris’s entire
medical record, plus the pleadings, affidavits, and other statements filed in the matter. Pet’r’s Ex.
11 at 1-2.

Dr. Engstrand is a licensed physician in the State of New York and has been board certified
in neurology for over twenty years. Pet’r’s Ex. 11 at 1. She currently is in private practice and has,
by her own assertion, treated thousands of patients with myalgia, fatigue, chronic pain, and
paresthesias – although she has never treated or personally evaluated Mr. Morris. Pet’r’s Ex. 12 at
1. Dr. Engstrand published several articles in the 1980s, specifically on issues concerning drug
abuse. Id. at 4.

Dr. Engstrand opines that Mr. Morris has “persistent neurological sequelae, fatigue,
myalgias, sensory changes and chronic diffuse pain disorder” caused by a “postvaccinal reaction”

4
to the TDaP vaccine he received in August of 2009. Pet’r’s Ex. 11 at 2. She proposes that the most
likely mechanism behind this reaction is Mr. Morris’s exposure to “immunostimulatory
compounds” in the vaccine, pointing to aluminum hydroxide as one such example. Id. at 2-3.
According to Dr. Engstrand, this exposure could precipitate an adverse autoimmune reaction, as
evidenced by Mr. Morris’s elevated ANA levels. Id.; Pet’r’s Ex. 17 at 2.

In support of her theory, Dr. Engstrand referenced six pieces of medical literature, five of
8
which specifically discuss an atypical form of myalgia known as macrophagic myofasciitis
(“MMF”).9 See F. Authier, et al., Central nervous system disease in patients with macrophagic
myofasciitis, 124 BRAIN 974-83 (2001) (ECF No. 50-3) [hereinafter “Authier”]; R.K. Gherardi,
Macrophagic myofasciitis lesions assess long-term persistence of vaccine-derived aluminum
hydroxide in muscle, 124 BRAIN 1821-31 (2001) (ECF No. 50-4) [hereinafter “Gherardi”]; R.K.
Gherardi, Lessons from macrophagic myofasciitis: towards definition of a vaccine adjuvant-
related syndrome, 159(2) REV. NEUROL. (PARIS) 162-64 (Feb. 2003) (ECF No. 50-5) [hereinafter,
“Gherardi II”]; P. Chérin, et al., Macrophagic myofasciitis. Study and Research Group on
Acquired and Dysimmunity-related muscular diseases (GERMMAD), 29(4) PRESSE MED 203-08
(Fed. 5, 2000) (ECF No. 50-6) [hereinafter “Chérin”]; and A. Ryan, et al., Atypical presentation
of macrophagic myofasciitis 10 years post vaccination, 16 NEUROMUSCULAR DISORDERS 867-69
(2006) (ECF No. 58-2) [hereinafter “Ryan”]. However, Dr. Engstrand’s reports do not specify the
relevance of these articles to Mr. Morris’s condition – for he has never been diagnosed with MMF,
he does not allege in this case that he suffered from it (despite his lack of diagnosis), and he
otherwise has not suggested that MMF is comparable in symptomology to what he claims to have
experienced.

Dr. Engstrand briefly mentioned that the pathophysiology behind the development of
vaccine-related MMF “is thought to be due to low-level stimulation of the immune system by the
aluminum hydroxide adjuvant in certain vaccines.” Pet’r’s Ex. 17 at 3; Ryan at 868. Some of the
literature she offered in support of her opinion explored the possibility of a link between MMF
and vaccines containing aluminum adjuvants. Authier at 981; Gherardi at 1821; Gherardi II at 1;
Ryan at 868. Dr. Engstrand pointed to Mr. Morris’s elevated ANA as evidence that he had
8
The last piece of literature offered by Petitioner is less directly relevant to his causation theory. N. Toplak, et al.,
Autoimmune response following annual influenza vaccination in 92 apparently healthy adults, 8(2) AUTOIMMUNITY
REVIEWS 134-38 (Dec. 1, 2008) (ECF No. 58(1)) [hereinafter “Toplak”]. Toplak examined whether there was an
increased autoimmune response – as evidenced by increased ANA values – after receipt of the annual influenza
vaccine. Id. at 1. But not only did Toplak consider an entirely different vaccine, it also (i) acknowledged that 26
percent of apparently healthy adults already have elevated ANA values unrelated to vaccines; and (ii) concluded that
there was no statistically significant difference in the percentage of those who had elevated ANA pre- and post-
vaccination. Id. Toplak is otherwise not discussed in either of Dr. Engstrand’s reports.

9
According to the literature cited by Petitioner’s expert, MMF is a newly-recognized condition manifested by diffuse
pain in the muscle(s) and highly specific myopathological (muscle disease (Dorland’s at 1224)) alterations. Authier
at 974.

5
experienced this type of “low-level stimulation of the immune system” after receipt of the TDaP
vaccine. Pet’r’s Ex. 17 at 3.

Dr. Engstrand also opined, somewhat inconsistently, that the timing of Mr. Morris’s
symptoms was medically appropriate and consistent with the aforementioned theory. Pet’r’s Ex.
11 at 3; Pet’r’s Ex. 17 at 2. In her first report, Dr. Engstrand concluded that it was appropriate for
Petitioner’s symptoms to have begun within two days of his TDaP vaccination (as he alleges
occurred). Pet’r’s Ex. 11 at 3. Dr. Engstrand’s supplemental report, however, argued that the
continuation of those same symptoms ten months later (when Petitioner first sought treatment)
“are consistent with the delayed adverse effects of vaccines.” Pet’r’s Ex. 17 at 2. In support of this
second point, she referenced Ryan as underscoring that symptoms of vaccine-related problems
could take up to ten years post-vaccination to develop. Pet’r’s Ex. 17 at 2 (citing Ryan). But Ryan
is a case study of a single individual who was diagnosed with MMF – again, not a diagnosis ever
proposed for Mr. Morris.

B. Dr. Chester V. Oddis

Respondent’s expert, Dr. Chester V. Oddis, filed a single expert report on June 8, 2015.
Resp’t’s Ex. A (ECF No. 53-1). In preparing it, Dr. Oddis reviewed all the medical records and
Mr. Morris’s affidavit, the petition, and Dr. Engstrand’s first expert report and accompanying
medical literature. Id. at 1. Dr. Oddis is board-certified in internal medicine and rheumatology. Id.
He is presently a Professor of Medicine in the Division of Rheumatology and Clinical Immunology
in the School of Medicine at the University of Pittsburgh. Id. He also sees patients, specializing in
the treatment of idiopathic inflammatory myopathies (“IIM”). Id.

Dr. Oddis’s opinion mostly attempted to refute the concept that Petitioner suffered from
any type of myositis (meaning inflammation of a voluntary muscle (Dorland’s at 1225)). See
generally Resp’t’s Ex. A at 3-4. Without any objective evidence of neurologic sequelae and
sensory changes, and given Petitioner’s unremarkable laboratory studies, such a diagnosis was
inappropriate, Dr. Oddis opined, regardless of Petitioner’s claims to the contrary.

In his report, Dr. Oddis recounted the spectrum of IIM, which includes several subsets of
myositis, including adult polymyositis (“PM”), the diagnosis he deemed most relevant in this case,
given Mr. Morris’s age and lack of dermatological symptoms, malignancy, and/or evidence of
other accompanying autoimmune disorders. Resp’t’s Ex. A at 3. According to Dr. Oddis, there are
several clinical features or criteria rheumatologists and neurologists use in order to diagnose adult
PM: (i) symmetric proximal muscle weakness10; (ii) increase in serum skeletal muscle enzymes;

10
According to Dr. Oddis, this is a generally painless, symmetric weakness, with difficulty performing activities which
require both upper and lower limb strength. Resp’t’s Ex. A at 3.

6
(iii) presence of a characteristic electromyographic (“EMG”) pattern; and (iv) muscle biopsy
evidence of myositis. Id. But Dr. Oddis opined that Mr. Morris’s medical records did not support
an adult PM diagnosis. None of Petitioner’s treating doctors ever found symmetric proximal
muscle weakness upon examination, Petitioner’s enzymes were never shown to be elevated, and
he never even had an EMG or muscle biopsy. Dr. Oddis found it especially significant that none
of Mr. Morris’s treaters ever proposed that he even undergo a biopsy. Id. at 3-4.

Dr. Oddis further concluded that Petitioner’s medical records did not support an MMF
diagnosis. In support of that aspect of his opinion, Dr. Oddis’s report discussed some of the medical
literature previously submitted by Petitioner. Authier, he maintained, bulwarked his conclusion
that Petitioner did not have MMF, because it recognized that MMF is manifested by “diffuse
myalgias and is characterized by highly specific myopathological findings showing macrophages,
T cell infiltration and myofiber damage.” Resp’t’s Ex. A at 3 (citing Authier). Petitioner’s medical
records, by contrast, did not reveal any such findings. Dr. Oddis further opined that individuals
properly diagnosed with MMF “have significant central nervous system features and abnormal
MRI11 findings.” Id. at 4. But such symptoms were never noted by any treater, nor was an MRI
ever performed for Mr. Morris. Id.

Moreover, Dr. Oddis continued, even if Petitioner had been diagnosed with some other
muscle condition that would explain his pain, there was no evidence from the medical records that
Petitioner ever experienced an autoimmune reaction to the TDaP vaccine. Resp’t’s Ex. A at 4. In
so maintaining, Dr. Oddis addressed the relevance of the elevated ANA finding (which Dr.
Engstrand highlighted in her supplemental report). Id. at 3. Dr. Oddis considered Mr. Morris’s
ANA value inconsequential, because Mr. Morris had not been shown to have an autoimmune
disease by other, confirming evidence. Id. Such an ANA value is therefore a “non-specific finding
as many individuals will have a ‘false positive’ ANA.” Id.

Finally, Dr. Oddis questioned whether Petitioner could under the circumstances establish
a medically acceptable temporal relationship between onset of his claimed symptoms and the
TDaP vaccine’s administration. In so doing, he referenced the Gherardi article filed by Petitioner’s
expert as supporting his opinion. Resp’t’s Ex. A at 4. Gherardi, he reasoned, established that the
median onset of myalgias in individuals with MMF is 11 months. Gherardi at 1821. As a result,
Petitioner’s assertion that he began experiencing symptoms as early as one week post-vaccination
was inconsistent with his theory of vaccine-induced MMF (assuming such a diagnosis was
supported by the facts). Resp’t’s Ex. A at 4.

11
MRI stands for magnetic resonance imaging. Dorland’s at 1184.

7
III. PROCEDURAL HISTORY

Mr. Morris filed his petition on June 26, 2012. Pet. (ECF No. 1). The records setting forth
the medical history summarized above were filed between July and mid-September of 2012.
Pet’r’s Exs. 1-10 (ECF Nos. 8, 10, 11). Mr. Morris thereafter filed a Statement of Completion on
September 25, 2012. ECF No. 12. Respondent opposed Mr. Morris’s claim, arguing that he could
not carry the burden of proof necessary to obtain a Vaccine Program award. See Nov. 9, 2012 Rule
4(c) report (ECF No. 13). In particular, Respondent asserted that the medical records revealed
merely that Mr. Morris had reported to his physicians his belief that the TDaP vaccine was related
to his illnesses – not that any of the physicians had themselves so opined. Id. at 8.

Following the filing of the Statement of Completion, Mr. Morris’s prior counsel
represented him in three telephone status conferences held in this matter in 2012 and 2013, while
Petitioner attempted to locate an expert. As reflected in Petitioner’s April and July 2013, status
reports, for a period of time the parties tried to resolve the matter informally. ECF Nos. 16, 18. But
such settlement talks reached an impasse, and Mr. Morris and his counsel spent some time
thereafter exploring how to proceed. ECF Nos. 22, 24.12 Counsel subsequently expressed his intent
to withdraw from the case.

In May of 2014, I granted Petitioner’s prior counsel’s request to withdraw,13 and Mr.
Morris proceeded with the case for a time as a pro se petitioner. Following a status conference
held on July 30, 2014, I ordered Petitioner to obtain and file a causation expert report and any
additional documents supporting his claim by October 31, 2014. ECF No. 40. Petitioner did so,
and also relayed his attempts to find an expert to opine on causation as well as alternative counsel.
ECF No. 41 at 1-2. Included in the filing were several exhibits, including a letter from Dr. Clarke,
letters from Mr. Morris’s family and friends, and three peer-reviewed journal articles. Id. at 5-49.

12
During this time, the case was re-assigned to me. ECF No. 20.
13
Respondent challenged counsel’s withdrawal, arguing that Petitioner should be ordered to show cause why the claim
should proceed if withdrawal was to be allowed. Resp’t’s Resp. at 1 (ECF No. 33). Petitioner replied on June 9, 2014,
arguing that Petitioner believed there was reasonable basis to his claim and was attempting to secure alternative
counsel to represent him. Pet’r’s Reply at 3 (ECF No. 36). The following day I issued an Order granting Petitioner’s
counsel’s Motion to Withdraw, despite Respondent’s objections, allowing Petitioner to continue on a pro se basis.
ECF No. 37.

Concurrent with his prior counsel’s withdrawal request, Petitioner also filed an application for interim attorney’s fees
and costs on February 11, 2014. ECF No. 28. Respondent opposed the fees request, arguing that Petitioner had failed
to demonstrate any of the necessary circumstances under Avera v. Sec’y of Health & Human Servs., 515 F.3d 1343
(Fed. Cir. 2008) to justify an interim fees award. ECF No. 29 at 3. Petitioner replied to Respondent’s arguments,
arguing, inter alia, that payment of interim fees was “consistent with congressional intent that Petitioners have access
to competent attorneys” and that given the procedural posture of the case such payment was appropriate at that time.
ECF No. 30. I deferred resolution of the interim fees request, finding that reasonable basis was an open and unresolved
question. ECF No. 34.

8
 After another status conference held on November 5, 2014, I again ordered Petitioner to
retain a medical expert to opine on causation and file a report to that effect, setting a new deadline
of January 9, 2015 by which to do so. ECF No. 43. In the intervening period, Petitioner obtained
new counsel, who became attorney of record as of December 4, 2014. ECF No. 44. I then held a
status conference on December 9, 2014, and extended Petitioner’s deadline to file an expert report
to February 13, 2015. ECF No. 45. The day before that deadline, Petitioner filed a motion
requesting that the deadline be extended further to May 13, 2015. ECF No. 46. Given the repeated
delays, I granted his request in part, extending the deadline only until March 31, 2015. Petitioner
adhered to the deadline and filed Dr. Engstrand’s first expert report. ECF No. 50. Respondent then
filed her responsive expert report and supporting materials from Dr. Oddis on June 8, 2015.

Petitioner thereafter accepted my suggestion that he submit a supplemental expert report
to further address the temporal gap between the alleged onset of Mr. Morris’s symptoms and when
he first presented for treatment eleven months later. ECF No. 55. Petitioner filed that supplemental
expert report from Dr. Engstrand on August 20, 2015 (ECF No. 57), followed by the literature
cited in her report. ECF No. 58. During a subsequent status conference held on September 29,
2015, I proposed, and the Parties agreed, to resolve the issue of entitlement on the basis of the
record and pleadings, rather than by holding a hearing. ECF No. 59. After granting an extension
of time, both Parties briefed the issue of entitlement.

Respondent briefed the matter by filing a Motion to Dismiss on January 19, 2016. ECF No.
64 (“Mot.”). In it, she argued that Petitioner had failed to meet his burden under the first two prongs
of the causation test established by the Federal Circuit in Althen v. Sec’y of Health & Human
Servs., 418 F.3d 1274 (Fed. Cir. 2005). Specifically, Petitioner had failed to offer a plausible
medical theory that establishes a logical sequence of cause and effect that is applicable and
consistent with Petitioner’s case. Mot. at 9-10. Respondent further argued that Petitioner had not
established an appropriate proximate temporal relationship, pointing out that Dr. Engstrand
vacillated in her analysis of what would constitute a medically-acceptable timeframe. Id. at 10-11.

Petitioner argued in favor of entitlement in a brief filed on January 22, 2016. ECF No. 65
(“Opp.”). He supported his claim by reference to Dr. Engstrand’s report, arguing that his myalgias,
chronic fatigue, and muscle pain following vaccination were well-documented and attributable to
receipt of immunostimulatory compounds used as vaccine adjuvants and contained in the TDaP.
Opp. at 5-6. He further argued that his diagnosis of fibromyalgia/myalgia/myositis was consistent
with Dr. Engstrand’s theory, and that onset of his injury (within two days of receiving the TDaP
vaccine) was consistent with the mechanism proposed by Dr. Engstrand. Id. at 6-8.

Petitioner also filed a reply on February 5, 2016, attempting to refute Respondent’s claim
that Dr. Engstrand had been inconsistent on the timing question, and pointing out purported logical

9
fallacies in Respondent’s expert report. ECF No. 66 at 4-5 (“Reply”).14 Petitioner also requested
in the reply (for the first time) that I defer ruling on entitlement (as the parties had previously
agreed was appropriate) pending performance of a muscle biopsy. Reply at 8-9. The issue of
entitlement is now ripe for a decision.

IV. APPLICABLE LEGAL STANDARDS

A. Petitioner’s Overall Burden in Vaccine Program Cases

To receive compensation in the Vaccine Program, a petitioner must prove either: (1) that
he suffered a “Table Injury” – i.e., an injury falling within the Vaccine Injury Table –
corresponding to one of the vaccinations in question within a statutorily prescribed period of time
or, in the alternative, (2) that his illnesses were actually caused by a vaccine (a “Non-Table
Injury”). See Sections 13(a)(1)(A), 11(c)(1), and 14(a), as amended by 42 C.F.R. § 100.3; §
11(c)(1)(C)(ii)(I); see also Moberly v. Sec’y of Health & Human Servs., 592 F.3d 1315, 1321 (Fed.
Cir. 2010); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1320 (Fed. Cir. 2006).15
No Table claim is asserted in this case, nor do I find the facts would support one.

Vaccine Program petitioners bear a “preponderance of the evidence” burden of proof.
Section 13(1)(a). A petitioner must offer evidence that leads the “trier of fact to believe that the
existence of a fact is more probable than its nonexistence before [he] may find in favor of the party
who has the burden to persuade the judge of the fact’s existence.” Moberly, 592 F.3d at 1322 n.2;
see also Snowbank Enter. v. United States, 6 Cl. Ct. 476, 486 (1984) (mere conjecture or
speculation is insufficient under a preponderance standard). Proof of medical certainty is not
required. Bunting v. Sec’y of Health & Human Servs., 931 F.2d 867, 873 (Fed. Cir. 1991). In
particular, a petitioner must demonstrate that the vaccine was “not only [the] but-for cause of the
injury but also a substantial factor in bringing about the injury.” Moberly, 592 F.3d at 1321
(quoting Shyface v. Sec’y of Health & Human Servs., 165 F.3d 1344, 1352-53 (Fed. Cir. 1999));
Pafford v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1355 (Fed. Cir. 2006).

14
Petitioner homed in on Respondent’s statement that “30% of patients with MMF developed myalgias within 3
months after immunization, 61% within a year and 80% within 2 years,” suggesting that it revealed a mathematical
error (as the sum of cited percentages exceeded 100) undercutting the reliability of Dr. Oddis’s opinion. Reply at 6.
In fact, it is Petitioner who is in error, since the percentages discussed encompass the previously-referenced
percentages; the 61 percent of MMF patients who develop myalgias within a year of vaccination logically includes
the smaller subset of patients who develop myalgias within three months.
15
Decisions of special masters (some of which I reference in this ruling) constitute persuasive but not binding
authority. Hanlon, 40 Fed. Cl. 625, 630 (1998). By contrast, Federal Circuit rulings concerning legal issues are binding
on special masters. Guillory v. Sec’y of Health & Human Servs., 59 Fed. Cl. 121, 124 (2003), aff’d, 104 F. App’x 712
(Fed. Cir. 2004); see also Spooner v. Sec’y of Health & Human Servs., No. 13-159V, 2014 WL 504728, at *7 n.12
(Fed. Cl. Spec. Mstr. Jan. 16, 2014).

10
 In attempting to establish entitlement to a Vaccine Program award of compensation, a
petitioner must satisfy all three of the elements established by the Federal Circuit in Althen: “(1) a
medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause
and effect showing that the vaccination was the reason for the injury; and (3) a showing of a
proximate temporal relationship between vaccination and injury.” Althen, 418 F.3d at 1278. A
petitioner may not receive a Vaccine Program award based solely on his assertions, however;
rather, the claim must be supported by either medical records or by the opinion of a competent
physician. Section 13(a)(1).

Each of the Althen prongs requires a different showing. Under Althen prong one, petitioners
must provide a “reputable medical theory,” demonstrating that the vaccine received can cause the
type of injury alleged. Pafford, 451 F.3d at 1355-56 (citations omitted). To satisfy this prong,
petitioner’s theory must be based on a “sound and reliable medical or scientific explanation.”
Knudsen v. Sec’y of Health & Human Servs., 35 F.3d 543, 548 (Fed. Cir. 1994). Such a theory
must only be “legally probable, not medically or scientifically certain.” Id. at 549.

Vaccine Program claimants may satisfy the first Althen prong without resort to medical
literature, epidemiological studies, demonstration of a specific mechanism, or a generally accepted
medical theory. Andreu v. Sec’y of Health & Human Servs., 569 F.3d 1367, 1378-79 (Fed. Cir.
2009) (citing Capizzano, 440 F.3d at 1325-26). Special masters, despite their expertise, are not
empowered by statute to conclusively resolve what are essentially thorny scientific and medical
questions, and thus scientific evidence offered to establish Althen prong one is viewed “not through
the lens of the laboratorian, but instead from the vantage point of the Vaccine Act’s preponderant
evidence standard.” Id. at 1380. Accordingly, special masters must take care not to increase the
burden placed on petitioners in offering a scientific theory linking vaccine to injury. Contreras v.
Sec’y of Health & Human Servs., 121 Fed. Cl. 230, 245 (2015) (“[p]lausibility . . . in many cases
may be enough to satisfy Althen prong one” (emphasis in original)).16

The second Althen prong requires proof of a logical sequence of cause and effect, usually
supported by facts derived from a petitioner’s medical records. Althen, 418 F.3d at 1278; Andreu,
569 F.3d at 1375-77; Capizzano, 440 F.3d at 1326; Grant v. Sec’y of Health & Human Servs., 956
F.2d 1144, 1148 (Fed. Cir. 1992). In establishing that a vaccine “did cause” injury, the opinions
and views of the injured party’s treating physicians are entitled to some weight. Andreu, 569 F.3d
at 1367; Capizzano, 440 F.3d at 1326 (“medical records and medical opinion testimony are favored
in vaccine cases, as treating physicians are likely to be in the best position to determine whether a

16
The first Althen prong has been interpreted to require a petitioner to propose (via reference to some kind of evidence)
a “plausible” causation theory, rather than establish with preponderant evidence. Nevertheless, the fact that the
causation theory may be established with a slightly lower evidentiary burden does not negate or reduce a petitioner’s
ultimate burden to establish his entitlement to damages by preponderant evidence. W.C. v. Sec’y of Health & Human
Servs., 704 F.3d 1352, 1356 (Fed. Cir. 2013) (citations omitted). That standard of proof governs the entire claim.

11
‘logical sequence of cause and effect show[s] that the vaccination was the reason for the injury’”)
(quoting Althen, 418 F.3d at 1280). Medical records are generally viewed as particularly
trustworthy evidence, since they are created contemporaneously with the treatment of the patient.
Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed. Cir. 1993).

However, medical records and/or statements of a treating physician’s views do not per se
bind the special master to adopt the conclusions of such an individual, even if they must be
considered and carefully evaluated. Section 13(b)(1) (providing that “[a]ny such diagnosis,
conclusion, judgment, test result, report, or summary shall not be binding on the special master or
court”); Snyder v. Sec’y of Health & Human Servs., 88 Fed. Cl. 706, 746 n.67 (2009) (“there is
nothing . . . that mandates that the testimony of a treating physician is sacrosanct—that it must be
accepted in its entirety and cannot be rebutted”). As with expert testimony offered to establish a
theory of causation, the opinions or diagnoses of treating physicians are only as trustworthy as the
reasonableness of their suppositions or bases. The views of treating physicians should also be
weighed against other, contrary evidence also present in the record – including conflicting opinions
among such individuals. Hibbard v. Sec’y of Health & Human Servs., 100 Fed. Cl. 742, 749 (2011)
(not arbitrary or capricious for special master to weigh competing treating physicians’ conclusions
against each other), aff'd, 698 F.3d 1355 (Fed. Cir. 2012); Caves v. Sec’y of Dep't of Health &
Human Servs., 100 Fed. Cl. 119, 136 (2011), aff'd, 463 F. App'x 932 (Fed. Cir. 2012); Veryzer v.
Sec’y of Health & Human Servs., No. 06-522V, 2011 WL 1935813, at *17 (Fed. Cl. Spec. Mstr.
Apr. 29, 2011), mot. for review den’d, 100 Fed. Cl. 344 (Sept. 29, 2011), aff’d, 475 Fed. App’x
765 (Fed. Cir. 2012).

The third Althen prong requires establishing a “proximate temporal relationship” between
the vaccination and the injury alleged. Althen, 418 F.3d at 1281. That term has been equated to the
phrase “medically-acceptable temporal relationship.” 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.” Bazan v.
Sec'y of Health & Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what
is a medically acceptable timeframe must also coincide with the theory of how the relevant vaccine
can cause an injury (Althen prong one’s requirement). Id. at 1352; Shapiro v. Sec’y of Health &
Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. den’d after remand, 105 Fed. Cl. 353 (2012),
aff’d mem., 2013 WL 1896173 (Fed. Cir. 2013); Koehn v. Sec'y of Health & Human Servs., No.
11-355V, 2013 WL 3214877 (Fed. Cl. Spec. Mstr. May 30, 2013), mot. for review den’d (Fed. Cl.
Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).

B. Fact Determinations

The process for making determinations in Vaccine Program cases regarding factual issues
begins with consideration of the medical records. Section 11(c)(2). The special master must
consider “all [] relevant medical and scientific evidence contained in the record,” including “any

12
diagnosis, conclusion, medical judgment, or autopsy or coroner’s report which is contained in the
record regarding the nature, causation, and aggravation of the petitioner’s illness, disability, injury,
condition, or death,” as well as “the results of any diagnostic or evaluative test which are contained
in the record and the summaries and conclusions.” Section 13(b)(1)(A). The special master is then
required to weigh the evidence presented, including contemporaneous medical records and
testimony. See Burns v. Sec’y of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (it is
within the special master’s discretion to determine whether to afford greater weight to
contemporaneous medical records than to other evidence, such as oral testimony surrounding the
events in question that was given at a later date, provided that such a determination is evidenced
by a rational determination).

Medical records that are created contemporaneously with the events they describe are
presumed to be accurate and “complete” (i.e., presenting all relevant information on a patient’s
health problems). Cucuras, 993 F.2d at 1528; Doe/70 v. Sec’y of Health & Human Servs., 95 Fed.
Cl. 598, 608 (2010) (“[g]iven the inconsistencies between petitioner’s testimony and his
contemporaneous medical records, the special master’s decision to rely on petitioner’s medical
records was rational and consistent with applicable law”), aff’d, Rickett v. Sec’y of Health &
Human Servs., 468 F. App’x 952 (Fed. Cir. 2011) (non-precedential opinion). This presumption is
based on the linked propositions that (i) sick people visit medical professionals; (ii) sick people
honestly report their health problems to those professionals; and (iii) medical professionals record
what they are told or observe when examining their patients in as accurate a manner as possible,
so that they are aware of enough relevant facts to make appropriate treatment decisions. Sanchez
v. Sec’y of Health & Human Servs., No. 11-685V, 2013 WL 1880825, at *2 (Fed. Cl. Spec. Mstr.
Apr. 10, 2013); Cucuras v. Sec'y of Health & Human Servs., 26 Cl. Ct. 537, 543 (1992), aff'd, 993
F.2d 1525 (Fed. Cir. 1993) (“[i]t strains reason to conclude that petitioners would fail to accurately
report the onset of their daughter’s symptoms. It is equally unlikely that pediatric neurologists,
who are trained in taking medical histories concerning the onset of neurologically significant
symptoms, would consistently but erroneously report the onset of seizures a week after they in fact
occurred”).

Accordingly, if the medical records are clear, consistent, and complete, then they should
be afforded substantial weight. Lowrie v. Sec’y of Health & Human Servs., No. 03-1585V, 2005
WL 6117475, at *20 (Fed. Cl. Spec. Mstr. Dec. 12, 2005). Indeed, contemporaneous medical
records are generally found to be deserving of greater evidentiary weight than oral testimony –
especially where such testimony conflicts with the record evidence. Cucuras, 993 F.2d at 1528;
see also Murphy v. Sec’y of Health & Human Servs., 23 Cl. Ct. 726, 733 (1991), aff'd, 968 F.2d
1226 (Fed. Cir.), cert. den’d, Murphy v. Sullivan, 506 U.S. 974 (1992) (citing United States v.
United States Gypsum Co., 333 U.S. 364, 396 (1947) (“[i]t has generally been held that oral
testimony which is in conflict with contemporaneous documents is entitled to little evidentiary
weight.”)).

13
 However, there are situations in which compelling oral testimony may be more persuasive
than written records, such as where records are deemed to be incomplete or inaccurate. Campbell
v. Sec’y of Health & Human Servs., 69 Fed. Cl. 775, 779 (2006) (“like any norm based upon
common sense and experience, this rule should not be treated as an absolute and must yield where
the factual predicates for its application are weak or lacking”); Lowrie, 2005 WL 6117475, at *19
(“[w]ritten records which are, themselves, inconsistent, should be accorded less deference than
those which are internally consistent”) (quoting Murphy v. Sec'y of Health & Human Servs., 23
Cl. Ct. 726, 733 (1991), aff'd per curiam, 968 F.2d 1226 (Fed. Cir. 1992)). Ultimately, a
determination regarding a witness’s credibility is needed when determining the weight that such
testimony should be afforded. Andreu, 569 F.3d at 1379; Bradley v. Sec’y of Health & Human
Servs., 991 F.2d 1570, 1575 (Fed. Cir. 1993).

C. Analysis of Expert Reports and Testimony

Establishing a sound and reliable medical theory often requires a petitioner to present
expert testimony in support of his claim. Lampe v. Sec’y of Health & Human Servs., 219 F.3d
1357, 1361 (Fed. Cir. 2000). Vaccine Program expert testimony is usually evaluated according to
the factors for analyzing scientific reliability set forth in Daubert v. Merrell Dow Pharm., Inc., 509
U.S. 579, 594-96 (1993). See Cedillo v. Sec’y of Health & Human Servs., 617 F.3d 1328, 1339
(Fed. Cir. 2010) (citing Terran v. Sec’y of Health & Human Servs., 195 F.3d 1302, 1316 (Fed. Cir.
1999)).17

The Daubert factors play a slightly different role in Vaccine Program cases than they do
when applied in other federal judicial fora (such as the district courts). Daubert factors are usually
employed by judges (in the performance of their evidentiary gatekeeper roles) to exclude evidence
that is unreliable and/or could confuse a jury. In Vaccine Program cases, by contrast, these factors
are used in the weighing of the reliability of scientific evidence proffered. Davis v. Sec’y of Health
& Human Servs., 94 Fed. Cl. 53, 66-67 (2010) (“uniquely in this Circuit, the Daubert factors have
been employed also as an acceptable evidentiary-gauging tool with respect to persuasiveness of
expert testimony already admitted”). The flexible use of the Daubert factors to evaluate the
persuasiveness of expert testimony has routinely been upheld. See, e.g., Snyder, 88 Fed. Cl. at 742-
45. In this matter (as in numerous other Vaccine Program cases), Daubert has not been employed
at the threshold, to determine what evidence should be admitted, but instead to determine whether
expert testimony offered is reliable and/or persuasive.

17
“The Daubert factors for analyzing the reliability of testimony are: (1) whether a theory or technique can be (and
has been) tested; (2) whether the theory or technique has been subjected to peer review and publication; (3) whether
there is a known or potential rate of error and whether there are standards for controlling the error; and (4) whether
the theory or technique enjoys general acceptance within a relevant scientific community.” Terran, 195 F.3d at 1316
n.2 (citing Daubert, 509 U.S. at 592-95).

14
 Respondent frequently offers one or more experts of her own in order to rebut a petitioner’s
case. Where both sides offer expert testimony, a special master’s decision may be “based on the
credibility of the experts and the relative persuasiveness of their competing theories.”
Broekelschen v. Sec’y of Health & Human Servs., 618 F.3d 1339, 1347 (Fed. Cir. 2010) (citing
Lampe, 219 F.3d at 1362). However, nothing requires the acceptance of an expert’s conclusion
“connected to existing data only by the ipse dixit of the expert,” especially if “there is simply too
great an analytical gap between the data and the opinion proffered.” Snyder, 88 Fed. Cl. at 743
(quoting Gen. Elec. Co. v. Joiner, 522 U.S. 146 (1997)); see also Isaac v. Sec’y of Health & Human
Servs., No. 08-601V, 2012 WL 3609993, at *17 (Fed. Cl. Spec. Mstr. July 30, 2012), mot. for
review den’d, 108 Fed. Cl. 743 (2013), aff’d, 540 Fed. App’x 999 (Fed. Cir. 2013) (citing Cedillo,
617 F.3d at 1339). Weighing the relative persuasiveness of competing expert testimony, based on
a particular expert’s credibility, is part of the overall reliability analysis to which special masters
must subject expert testimony in Vaccine Program cases. Moberly, 592 F.3d at 1325-26
(“[a]ssessments as to the reliability of expert testimony often turn on credibility determinations”);
see also Porter v. Sec’y of Health & Human Servs., 663 F.3d 1242, 1250 (Fed. Cir. 2011) (“this
court has unambiguously explained that special masters are expected to consider the credibility of
expert witnesses in evaluating petitions for compensation under the Vaccine Act”).

V. ANALYSIS

It is within a special master’s discretion to determine whether, in resolving a petition, a
hearing is required or rather if the matter can be resolved without live testimony, based solely on
the paper filings in a case. Vaccine Rule 8(d). In this instance, I determined that Mr. Morris’s
entitlement to a Vaccine Program award could be resolved without hearing, and the Parties agreed
to my proposed method of resolution. After a thorough and complete consideration of the
pleadings, briefs, and record, I have concluded that Mr. Morris has not established by preponderant
evidence entitlement to compensation in this case.

First, Petitioner’s expert embraces a causation theory that relies on a factual determination
– that Mr. Morris had MMF – that is unsupported by the record. Second, application of the Althen
prongs reveals additional evidentiary deficiencies of Petitioner’s claim: (a) Petitioner has failed to
offer a persuasive or reliable medical theory; (b) the theory provided is not applicable to the facts
of Petitioner’s case; and (c) Petitioner has not established a medically acceptable timeframe in
which his symptoms could have begun or developed.

A. Mr. Morris Cannot Demonstrate that He Suffered from MMF.

A prominent deficiency in Petitioner’s case is the extent to which his causation theory
assumes he suffered from a disease that is not established by the record. Petitioner’s causation
theory is heavily dependent on literature exploring an association between certain vaccines and

15
development of MMF, and thus implicitly relies on a determination that Mr. Morris’s symptoms
were consistent with MMF. See, e.g., Authier; Gherardi. As the parties generally agree, MMF “is
manifested by diffuse myalgias and is characterized by highly specific myopathological findings
showing macrophages, T cell infiltration and myofiber damage” reflected in the results of a muscle
biopsy. Resp’t’s Ex. A at 3; Authier at 974.18

In this case, however, there is no record evidence that Petitioner had MMF. First, none of
Mr. Morris’s treaters ever diagnosed him with MMF, opting instead (and mainly on the basis of
his subjective reports of pain) to characterize his condition more vaguely, as
“fibromyalgia/myalgia/myositis.” Pet’r’s Ex. 3 at 7.19 Dr. Engstrand for her part does not offer a
persuasive reading of the medical records to suggest that an MMF diagnosis is still possible under
the circumstances, by pointing to actual evidence that would support it.

Second, there are no test results found in the record that would support such a diagnosis.
Mr. Morris never received a muscle biopsy, which is, according to Dr. Oddis, the “gold standard”
for diagnosing MMF as well as myositis more generally. ECF No. 53-1 at 3. Mr. Morris attempted
to explain the absence of such testing as attributable to his lack of insurance and logistical
hardships. Opp. at 6. However, there is no mention or suggestion by any of his treaters that such a
test was recommended or even contemplated. I infer from the fact that the treaters in this case did
not see the need to perform a muscle biopsy (given the absence of other confirmatory test results)
as reasonably suggesting that those treaters were not concerned about the possibility of MMF
under the circumstances. Such a record lacks preponderant evidence that Mr. Morris suffered from
MMF – and in fact supports the opposite conclusion.

B. The Althen Prongs Have not Been Satisfied.

1. Althen Prong One - A petitioner’s causation theory must be based on a
“sound and reliable medical or scientific explanation.” Knudsen, 35 F.3d at 548. Petitioner’s
causation theory, however, has several evident deficiencies. To begin with (as discussed above),
Dr. Engstrand’s literature focuses almost solely on studies demonstrating an association between
vaccinations and MMF – even though the evidence does not suggest Petitioner suffered from

18
Respondent’s expert also asserted that central nervous system features and abnormal MRI findings are found with
patients suffering from MMF (Resp’t’s Ex. A at 4), although the literature does not suggest that such symptoms are
common to all or even most patients with MMF. See, e.g., Authier at 974 (only 8 of 92 MMF patients had symptomatic
demyelinating central nervous system disorders). I have therefore focused on the issue of muscle biopsy instead, which
the parties agree is a relevant test for MMF. Opp. at 8-9.

19
There is little difference between the symptoms of fibromyalgia, myalgia, and myositis. Fibromyalgia is
characterized by pain and stiffness in the muscles and joints (Dorland’s at 703); myalgia is pain in a muscle(s)
(Dorland’s at 1214); and myositis is an inflammation of a voluntary muscle. Dorland’s at 1225.

16
MMF. As a result, regardless of whether these studies persuasively suggest a relationship between
“aluminum-containing vaccines” (specifically the hepatitis-B vaccine; hepatitis-A vaccine, and/or
tetanus toxoid vaccines) and MMF (Authier at 974, 976; Gherardi at 1821) they are not on point
herein, weakening the “fit” between the expert opinion offered and the facts of the case. Daubert,
509 U.S. at 591. Insufficiently relevant literature has been offered linking the TDaP vaccine to the
more vague symptoms Mr. Morris actually suffered.

Next, specific elements of the theory by which the TDaP vaccine could cause myalgia to
develop are highly unreliable (at least under the present state of the science). In particular, Dr.
Engstrand’s medical theory proposes that an adjuvant (aluminum hydroxide) in the TDaP vaccine
Mr. Morris received stimulated and precipitated an autoimmune reaction resulting in his
symptoms. This is not the first time that this medical theory has been asserted in the Vaccine
Program, although it is often referred to as “Autoimmune Syndrome Induced by Adjuvants” or
“ASIA.” See, e.g., Rowan v. Sec’y of Health & Human Servs., No. 10-272V, 2014 WL 7465661
(Fed. Cl. Spec. Mstr. Dec. 8, 2014), mot. for review den’d, 2015 WL 3562409 (Fed. Cl. May 18,
2015). But no special masters have ever found ASIA or ASIA-related theories to be persuasive.
See, e.g., Rowan, 2014 WL 7465661, at *12 (denying entitlement to Petitioner who claimed the
aluminum adjuvant in the HPV vaccine caused her headaches, migraines, and chronic fatigue
syndrome); see also Bushnell v. Sec’y of Health & Human Servs., No. 02-1648V, 2015 WL
4099824, at *18 (Fed. Cl. Spec. Mstr. June 12, 2015) (denying compensation in a case that alleged
that an aluminum adjuvant allegedly exacerbated a mitochondrial disorder and precipitated
autism); Harris v. Sec’y of Health & Human Servs., No. 10-322V, 2014 WL 3159377, at *16 (Fed.
Cl. Spec. Mstr. June 10, 2014) (noting that aluminum adjuvants are considered to be safe and have
been used for nearly a century); Hennessey v. Sec’y of Health & Human Servs., No. 01-190V, 2009
WL 1709053 (Fed. Cl. Spec. Mstr. May 29, 2009) (petitioner failed to prove by preponderant
evidence that the adjuvant in a hepatitis B vaccine caused type 1 diabetes), mot. for review den’d,
91 Fed. Cl. 126 (2010).

Dr. Engstrand’s report presents the adjuvant component of her theory as accepted science,
when this is anything but the case. See, e.g., Rowan, 2014 WL 7465661, at *6-7 (“ASIA is not a
proven theory…the data only ‘suggest the possibility of accelerated autoimmunity/inflammation
following vaccination’” and “precisely how adjuvants cause autoimmune illness ‘is not always
known’”). Absent corroborative evidence – whether in the form of additional literature or a reliable
scientific study – lending support to the concept, I cannot accept her conclusory views as to the
impact an adjuvant could have under such circumstances, and I therefore do not find that she has
provided a persuasive explanation for how the TDaP vaccine might have resulted in symptoms
akin to those experienced by Petitioner.20

20
In addition, testimony about the biochemical effects of a vaccine and/or its subcomponents is also well outside of
Dr. Engstrand’s individual expertise. In determining whether a particular expert’s testimony is reliable or credible, I
may consider whether the expert is offering an opinion that exceeds the expert’s training or competence. Walton v.

17
 Beyond the above, Dr. Engstrand’s opinion simply does too little to offer a plausible
scientific or medical explanation for how the TDaP vaccine could affect an individual in the
manner alleged to have been experienced herein – an immediate reaction followed by months of
pain that was nevertheless tolerable enough to delay medical treatment. Otherwise, Petitioner has
not put forth any opinions, case studies, or medical literature putting forth a theory by which the
TDaP vaccine could have caused his injury. Accordingly, Petitioner has not offered a sufficiently
plausible causation theory.

2. Althen Prong Two – Even if Petitioner’s causation theory was not
contingent upon finding that he suffered from MMF, there is no evidence in Mr. Morris’s medical
records that the TDaP vaccine he had any injury via an autoimmune response. Mr. Morris’s own
statements about his immediate post-vaccination condition are not corroborated by
contemporaneous medical records, as Mr. Morris did not seek medical treatment for months after
the vaccination. Compare Pet’r’s Ex. 7 at ¶¶ 5-6 with Pet’r’s Ex.1 at 4. When Mr. Morris finally
did so, his treaters found no objective evidence of anything wrong with him. Pet’r’s Ex. 1 at 4, 10-
11; Pet’r’s Ex. 4 at 2. In addition, his physical exams and laboratory results were largely normal
and not indicative of any underlying problem. Id. And none of his treaters accepted or endorsed
Petitioner’s belief of a possible link between his symptoms and the TDaP vaccine, nor did they see
evidence of an autoimmune reaction, such as inflammation. Pet’r’s Ex. 3 at 4.

Mr. Morris has offered his own statements, plus those of family members, to supplement
holes in the medical records and thus to establish that he was in fact suffering the effects of the
TDaP vaccine sooner than the medical records establish. Mr. Morris has also provided an
explanation for why he did not seek earlier treatment. Nevertheless – the absence of medical
evidence for so long a time from the date of vaccination to his first doctor’s visit strongly, and
reasonably, suggests that Mr. Morris’s condition was not sufficiently severe to pursue treatment,
which casts doubt on the likelihood that he was experiencing a debilitating autoimmune reaction
that began in August 2009. Certainly his personal testimony, and that of the other witness
statements, is by itself insufficient to establish his claim, where not corroborated by other
independent, reliable evidence. Section 13(a)(1); See, e.g., Veryzer v. Sec’y of Health & Human
Servs., No. 06-522, 2010 WL 5185485, at *4 (Fed. Cl. Spec. Mstr. Aug. 9, 2010) (dismissing a

Sec’y of Health & Human Servs., No. 04-503V, 2007 WL 1467307, at *17-18 (Fed. Cl. Spec. Mstr. Apr. 30, 2007)
(otolaryngologist not well suited to testify about disciplines other than her own specialty). While (in keeping with the
liberality with which evidence offered in Vaccine Program cases is treated) I read and have evaluated all of the
testimony of the experts offered in this case, I may give appropriate weight to whether certain testimony is beyond a
particular expert’s purview. See e.g., King v. Sec’y of Health & Human Servs., No. 03-584V, 2010 WL 892296, at
*78-79 (Fed. Cl. Spec. Mstr. Mar. 12, 2010) (petitioner’s expert far less qualified to offer opinion on general causation
issues pertaining to autism than specific issues pertaining to the petitioner’s actual medical history, given the nature
of the expert’s qualifications).

18
case on the grounds that petitioner failed to meet burden under Althen two because there were no
medical records or medical expert testimony to corroborate petitioner’s claim).

Dr. Engstrand’s supplemental report does reference Petitioner’s somewhat elevated ANA
level as evidence of an autoimmune response. Pet’r’s Ex. 17 at 2. But I find Respondent’s
evaluation of that test result to be more persuasive. As Dr. Oddis explained in his expert report, an
ANA at a low positive titer of 1:80 in a homogeneous pattern (Mr. Morris’s value) is nonspecific
and likely a false positive. Resp’t’s Ex. A at 5. Tellingly, Dr. Engstrand agreed (at least in her
initial report) that Mr. Morris’s rheumatology work up was “essentially negative,” (Pet’r’s Ex 11
at 2) and Petitioner’s entitlement brief also downplayed the value of this test result. Opp. at 3.

There is thus insufficient evidence in the medical records of any type of autoimmune
reaction in response to the TDaP vaccine for me to find that the TDaP vaccine “did cause” Mr.
Morris’s symptoms.

3. Althen Prong Three - Petitioner alleges that his reaction to the TDaP vaccine
began within a week of its administration, which in turn produced pain and related symptoms that
purportedly went on for months. To satisfy his initial burden on the third Althen prong, Petitioner
needed to demonstrate that this was a medically appropriate timeframe. In her initial report,
however, Dr. Engstrand conclusorily represents that this is the case, with little explanation for why.
Pet’r’s Ex. 11 at 3. At best, she relies on Ryan, which avers that symptoms of vaccine-related
problems can develop any time up to ten years post-vaccination – an open-ended proposition that
would be enough to establish nearly any timeframe. Pet’r’s Ex. 17 at 2 (citing Ryan). Moreover,
Ryan also involves MMF – a diagnosis not supported by the facts in this case. Such factors,
coupled with the other problems with Petitioner’s causation theory, make it impossible for me to
find that he has met this Althen prong.

There is also a contradiction between Dr. Engstrand’s explanation of the timing element in
her theory and the record. Dr. Engstrand’s supplemental expert report (filed after I ordered
Petitioner to better explain the delay between onset as alleged by Petitioner and Petitioner’s first
doctor’s visits 10 months later (ECF No. 54 at 1)), opined specifically that “[t]hese symptoms
occurring 10 months later are consistent with the delayed adverse effects of vaccines.” Id. at 2
(emphasis added). Indeed, one of the articles relied upon by Dr. Engstrand supports the conclusion
that the median time to develop MMF (again, not a diagnosis supported by the evidence) is 11
months. Pet’r’s Ex. 14. Dr. Oddis accepted the same time period of time as reasonable in actual
cases of MMF. ECF No. 53-1 at 4. But this is completely inconsistent with Petitioner’s allegations
that he experienced a reaction within days of the vaccination, and that his resulting pain and
weakness persisted for months thereafter. To the extent it is Petitioner’s contention that he actually
suffers from MMF (as the thrust of Dr. Engstrand’s report and literature suggests), his own
allegations of onset would undermine the core aspect of his own expert’s causation theory.

19
VI. REQUEST TO DEFER RULING PENDING TESTING

Petitioner’s Reply proposes that I defer ruling pending his receipt of a muscle biopsy,
which, he argues, would potentially corroborate his contention that he suffered from vaccine-
induced MMF. Reply at 8-9. I shall not do so, for both substantive and procedural reasons.

Substantively, Petitioner has not shown that the results of a muscle biopsy test would likely
alter the outcome of the case in his favor. Vant Erve v. Sec’y of Health & Human Servs., 39 Fed.
Cl. 607 (1997), aff’d after remand, 232 F.3d 914 (Fed. Cir. 2000) (allowing reopening of the record
to introduce new evidence where, among other things, the probative nature of the proposed new
evidence outweighs other considerations, such as delay or prejudice to the nonmoving party);
Snyder, 88 Fed. Cl. at 739 (upholding denial of petitioners’ motion to supplement the factual
record). Grounds for additional testing might be compelling if one of Mr. Morris’s treaters had
previously proposed it, or if other test results performed on Petitioner provided direct or
circumstantial support for an MMF diagnosis that could be corroborated with a muscle biopsy. But
no such evidence or treatment recommendations exist under present circumstances. Indeed,
Petitioner has filed no medical records detailing his treatment history after mid-2011. Absent some
reliable, persuasive indication that taking the time to allow further testing would be fruitful, I need
not refrain from deciding entitlement at this late stage of the proceeding simply because Petitioner
hopes that additional evidence could swing the balance in his favor. Vaccine Rule 7(a) (“[t]here is
no discovery as a matter of right”).

Procedurally, the request for more testing is dilatory. Stone v. Sec’y of Health & Human
Servs., 676 F.3d 1373, 1385-86 (Fed. Cir. 2012) (not an abuse of discretion for special master to
deny motion to submit additional evidence, when (i) the “new” evidence was known and available
earlier, and thus could have been submitted in a timely fashion; and (ii) it was unclear if the
additional evidence would have strengthened the case). This case is four years old, and Petitioner
has had representation for most of its history. Thus, the possibility that additional testing could
strengthen his claim should have been discovered long ago.21 I also alerted Petitioner to the facial
weaknesses of his claim in my June 23, 2015, scheduling order (after having reviewed Dr. Oddis’s
expert report, which expressly identified a muscle biopsy as useful in diagnosing MMF). See, e.g.,
ECF No. 54 at 1. Such testing should have been requested before Petitioner accepted my proposal
that the case be resolved on the papers – not in a reply brief.

21
Indeed, Petitioner’s original counsel’s request for an award of interim attorney’s fees establishes that they had the
case for almost two years before it was filed (Morris v. Sec’y of Health & Human Servs., No. 12-415V, 2014 WL
8661863, at *7 (Fed. Cl. Spec. Mstr. June 4, 2014)), and took additional time afterwards to locate an expert before
withdrawing from the matter. Petitioner has had ample time to determine the benefits of a muscle biopsy, let alone
obtain one.

20
 CONCLUSION

I do not question Mr. Morris’s sincerity in proceeding with his claim. But the factual record
does not support his contention that his symptoms were caused by – or are even related to – his
receipt of the TDaP vaccine. I therefore DENY an entitlement award in this case. I instruct the
Clerk of Court to enter judgment dismissing the case unless a motion for review is filed.22

IT IS SO ORDERED.

/s/ Brian H. Corcoran
Brian H. Corcoran
Special Master

22
Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.

21