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.
2

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 selfmedicated 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, 
3

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. 
4

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” 
5

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 

which8 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 adjuvantrelated 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 postvaccination. 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. 
6

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. 
7

(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. 
8

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. 
9

 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 
10

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). 
11

 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.
12

‘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 
13

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.”)). 
14

 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). 
15

 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 
16

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. 
17

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. 
18

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). 
19

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.
20

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 vaccineinduced 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. 
21

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.