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