VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_16-vv-00551
Package ID: USCOURTS-cofc-1_16-vv-00551
Petitioner: A.S.
Filed: 2016-08-27
Decided: 2019-10-11
Vaccine: DTaP
Vaccination date: 2013-05-07
Condition: neurologic neglect syndrome, expressive language disorder, unspecified disorders of the nervous system, and immune dysfunction
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On May 5, 2016, Guy Sterling filed a petition on behalf of his minor son, A.S., seeking compensation under the National Vaccine Injury Compensation Program. The petition alleged that vaccines received on May 7, 2013, and July 26, 2013, caused or significantly aggravated unspecified injuries. The petitioner later amended the claim to specify that the pneumococcal conjugate PCV-13, Hemophilus influenzae type B (Hib) (PRP-T), and diphtheria-tetanus-acellular pertussis (DTaP) vaccines administered on May 7, 2013, caused neurologic neglect syndrome, expressive language disorder, unspecified disorders of the nervous system, and immune dysfunction. The respondent moved to dismiss, arguing that A.S.'s condition was autism spectrum disorder (ASD). The medical records indicated that developmental delay and speech regression were first noted at A.S.'s two-year well-child visit on January 27, 2014, over eight months after the May 2013 vaccinations. Specialists assessed him with severe receptive and expressive language disorder, and the parents reported concerns about ASD-like features. Petitioner's experts, Dr. Toni Bark and Dr. James Lyons-Weiler, argued for vaccine-induced encephalopathy. Respondent's experts, Dr. Max Wiznitzer and Dr. Jeffrey Johnson, maintained that A.S.'s condition was likely ASD and not vaccine-related, and that the petitioner's experts' causation theories were unsupported by the cited literature. The Special Master, Brian H. Corcoran, found no preponderant evidence of post-vaccination encephalopathy, either Table or non-Table, and noted that the petitioner's causation theory was inconsistent with established caselaw regarding vaccine-caused autism. The Special Master concluded that the claim lacked a reasonable basis and failed to establish causation, and therefore dismissed the petition. Petitioner was represented by Clifford J. Shoemaker, and Respondent was represented by Voris E. Johnson. The decision was issued on October 11, 2019.

Theory of causation field:
Petitioner alleged that the DTaP, PCV-13, and Hib vaccines administered on May 7, 2013, caused neurologic neglect syndrome, expressive language disorder, unspecified disorders of the nervous system, and immune dysfunction. Petitioner's experts, Dr. Toni Bark and Dr. James Lyons-Weiler, proposed theories of vaccine-induced encephalopathy. Dr. Bark suggested aluminum adjuvants could cause harm at the genetic level and lead to chronic microglial cell activation. Dr. Lyons-Weiler posited that thimerosal and aluminum could cause immunological response dysfunction and that acetaminophen given after vaccination could lead to glutathione depletion and excitotoxicity, mimicking brain injury. Respondent's experts, Dr. Max Wiznitzer and Dr. Jeffrey Johnson, refuted these theories, arguing they were unsupported by scientific literature and that A.S.'s condition was likely autism spectrum disorder. The Special Master found no preponderant evidence of post-vaccination encephalopathy, either Table or non-Table, noting that the medical records did not show an acute encephalopathy within a medically acceptable timeframe after vaccination, and that the developmental delays were first noted over eight months post-vaccination. The Special Master also found Petitioner's causation theory inconsistent with established caselaw regarding vaccine-caused autism, leading to dismissal of the claim. The case was dismissed on October 11, 2019, with Petitioner represented by Clifford J. Shoemaker and Respondent by Voris E. Johnson.

Public staged source text:

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DOCUMENT 1: USCOURTS-cofc-1_16-vv-00551-0
Date issued/filed: 2019-10-11
Pages: 17
Docket text: PUBLIC DECISION (Originally filed: 08/27/2019) regarding 68 DECISION of Special Master. Signed by Chief Special Master Brian H. Corcoran. (bm) Service on parties made.
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Case 1:16-vv-00551-UNJ Document 72 Filed 10/11/19 Page 1 of 17
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 16-551V
(not to be published)
* * * * * * * * * * * * * * * * * * * * *
A.S., *
by his father and natural guardian, * Special Master Corcoran
GUY STERLING, *
*
Petitioner, * Filed: August 27, 2019
*
v. * Autism Spectrum Disorder; Dismissal;
* Encephalopathy.
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
*
* * * * * * * * * * * * * * * * * * * * *
Clifford J. Shoemaker, Shoemaker, Gentry & Knickelbein, Vienna, VA, for Petitioner.
Voris E. Johnson, U.S. Dep’t of Justice, Washington, DC, for Respondent.
DECISION DISMISSING PETITION1
On May 5, 2016, Guy Sterling filed a petition on behalf of his minor son, A.S., seeking
compensation under the National Vaccine Injury Compensation Program (the “Vaccine
Program”).2 ECF No. 1. He initially alleged that “multiple vaccines” A.S. received on May 7,
2013, and July 26, 2013, caused or significantly aggravated unspecified injuries. Id. at 1. He later
amended his claim to specify that the pneumococcal conjugate PCV-13, Hemophilus influenzae
type B (“Hib”) (PRP-T), and diphtheria-tetanus-acellular pertussis (“DTaP”) vaccines
1 Although I am not formally designating this Decision for publication, it will nevertheless be posted on the Court of
Federal Claims’s website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means
the Decision will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B),
however, the parties may object to the 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 Decision will be available to the public in its
current form. 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.

Case 1:16-vv-00551-UNJ Document 72 Filed 10/11/19 Page 2 of 17
administered to A.S. on May 7, 2013, caused neurologic neglect syndrome, expressive language
disorder, unspecified disorders of the nervous system, and immune dysfunction. Am. Pet. at 3,
filed Apr. 14, 2017 (ECF No. 24).
Asserting that A.S.’s proper diagnosis is autism, Respondent moved to dismiss
Petitioner’s claim with the filing of his Rule 4(c) Report on June 2, 2017. See generally ECF
No. 27. Because the parties disputed A.S.’s diagnosis, both parties filed expert reports in support
of their positions. After reviewing these reports, I decided to resolve this matter without hearing,
and the parties filed briefs in support of their respective positions in the spring of 2019. See Mem.
in Supp. of Entitlement, filed Mar. 29, 2019 (ECF No. 63) (“Mem.”); Resp’t’s Resp. to Pet’r’s
Mem. in Supp. of Entitlement, filed May 9, 2019 (ECF No. 65) (“Opp.”); Reply to Resp’t’s Resp.
to Mem. in Supp. of Entitlement, filed May 28, 2019 (ECF No. 66) (“Reply”).
Having now had the opportunity to review the medical records, expert reports, and
arguments of both parties, I find that Respondent’s motion to dismiss is well-founded. For the
reasons set forth below, I hereby dismiss Petitioner’s claim.
I. A.S.’s Medical History
Early History and May 2013 Vaccinations
A.S. was born at term via cesarean section on January 7, 2012. Ex. 1 at 4–5, filed July 22,
2016 (ECF No. 8-2). He was born healthy with no complications, and was discharged home on
January 10th. Id. at 2. He received the Hepatitis B (“Hep B”) vaccine on the day of his birth, with
no recorded reaction. Ex. 2 at 79, filed July 22, 2016 (ECF No. 8-3). No concerns were noted at
a newborn checkup with Stephen Cooper, M.D., on January 12th. Id. at 79–81.
Throughout the first nine months of his life, A.S. saw Dr. Cooper regularly for well-child
visits. Ex. 2 at 64–78. A.S. presented with conjunctivitis at a January 20, 2012 visit, but this
quickly improved with medication. Id. at 74, 77. A.S. next received the DTaP, Hib, polio,
pneumococcal, and rotavirus vaccines, as well as a second round of Hep B, at a March 9th
checkup. Id. at 73. He received a second round of DTaP, Hib, polio, pneumococcal, and rotavirus
vaccines two months later on May 9th. Id. at 67. Dr. Cooper also recorded that A.S. had
torticollis—a left head tilt—at the May 9th checkup. Id. at 69, 71. A.S. received a third round of
the DTaP, Hib, polio, Hep B, pneumococcal, and rotavirus vaccines on July 12th, again without
incident. Id. at 64–65. On September 20th, his mother brought him to see Jerry Clayville, M.D.,
concerned about an “occasional raspy sound” A.S. was making. Id. at 64. Dr. Clayville diagnosed
A.Z. with gastroesophageal reflux and prescribed Zantac. Id. at 66.
At his nine-month well-child checkup on October 12, 2012, A.S.’s fine motor skills were
characterized as “borderline,” but no other concerns were noted. Ex. 2 at 60–63. He received the
influenza (“flu”) vaccine at this visit. Id. at 63. He received a second flu shot one month later on
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November 13th. Id. at 56. At his twelve-month checkup on January 9, 2013, A.S. was able to
stand independently, crawl, and say a few words. Id. at 54. He had eczema, but was otherwise
normal on examination. Id. at 55. He received the measles-mumps-rubella (“MMR”), varicella,
and Hepatitis A (“Hep A”) vaccines on this date. Id. at 55. Six days later on January 15th, A.S.
presented to Dr. Clayville with cough, loss of appetite, and a fever, which Dr. Clayville thought
might be a viral syndrome with croup-like features. Id. at 49–52. He also suspected that A.S. had
viral-induced leukopenia and neutropenia. Id. at 52. A.S. was referred to the emergency room
(“ER”) for further evaluation, where he was diagnosed with a viral disease. Ex. 3 at 4, filed
July 22, 2016 (ECF No. 8-4). A.S. returned to the ER just over one month later on February 24th
with a fever, cough, ear pain, and a runny nose. Id. at 10–11. He was again diagnosed with a
virus. Id. at 12.
On May 7, 2013, A.S. saw Dr. Clayville for his fifteen-month checkup. Ex. 2 at 40. No
developmental concerns were noted, and A.S. was then able to say more than six words. Id. at 42.
He received his fourth DTaP, pneumococcal, and Hib vaccinations at this visit. Id. at 43. The
medical record shows no evidence of a reaction to these vaccinations, and when A.S. next saw
Dr. Clayville for a checkup on July 26th, the Sterlings made no recorded mention of a post-
vaccination reaction any time after the previous visit. Id. at 38. At the July 26th visit, A.S. passed
a developmental screen,3 and his vocabulary was documented as “7+ words.” Id. at 38–39. He
received a second Hep A vaccine, again with no documented reaction. Id. at 39. Three months
later, on October 15th, A.S. saw Dr. Clayville for receipt of the flu vaccine. Id. at 32. No
assessment of A.S.’s development was made at that visit, but neither were developmental
concerns reported. See id. He was later seen on November 19th for cold symptoms without fever,
which Dr. Clayville diagnosed as an upper respiratory infection. Id. at 26–29.
Recorded Reports of Developmental Delay
A.S.’s developmental delay was first noted at his two-year well-child visit on January 27,
2014 (now eight months after the May 2013 vaccinations). Ex. 2 at 21–26. At this time, Dr.
Clayville observed that A.S. knew fewer than ten words, and that he “seem[ed] to be decelerating
in acquisition of words.” Id. at 24. He failed communication and problem solving components of
a developmental screening, and was “borderline” in the personal-social skills category. Id. at 25.
His condition was assessed as expressive language delay, and Dr. Clayville noted concern for a
possible autism spectrum disorder (“ASD”). Id. at 26.
In the weeks following Dr. Clayville’sassessment, A.S. underwent evaluations by several
specialists. He saw a speech therapist on February 3, 2014. Ex. 11 at 22–25, filed Nov. 29, 2016
(ECF No. 13-9). He was assessed with “a severe receptive and expressive language disorder,”
which the speech therapist thought could be attributed to hearing deficits, “or some other
3 Although this developmental screening was performed as A.S.’s eighteen-month checkup, the age group listed for
the screening is nine months. Ex. 2 at 39. There is no clear explanation in the medical record for this discrepancy.
3

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underlying pathology which warrants assessment of hearing acuity and behavioral concerns.” Id.
at 24–25. A.S. next saw an ear, nose, throat, and allergy specialist, Michael Kelleher, M.D., on
February 7th. Ex. 6 at 2–4, filed Nov. 29, 2016 (ECF No. 13-4). Dr. Kelleher found A.S.’s hearing
to be normal, and diagnosed him with gastroesophageal reflux and “[o]ther developmental speech
or language disorder.” Id. at 2. The Sterlings reported to Dr. Kelleher that A.S. “may demonstrate
some of the features of Autism.” Id. at 3. Dr. Kelleher explained that he was not qualified to opine
as to the accuracy of a possible ASD diagnosis, and that they should consult with a pediatrician
or childhood development specialist. Id. Six days later, A.S. underwent a developmental
evaluation, in which he was described as having a 25% delay in communication, cognitive, and
social-emotional skills. Ex. 17 at 34–36, filed Nov. 29, 2016 (ECF No. 14-6).
A.S. saw an occupational therapist on July 16, 2014. Ex. 11 at 28–32. At this evaluation,
the Sterlings reported that A.S. “had been doing very well with meeting his milestones until he
got a viral infection after his immunization shots and he had a very high fever,” after which “he
seemed to [lose] some of his language skills and seemed to get further and further behind.” Id.
at 28. His diagnosis at this evaluation was “neurologic neglect syndrome.” Id. At a physical
therapy exam on October 7th, A.S.’s condition was characterized as “developmental delay” and
“unspecified disorder of the nervous system.” Id. at 35, 37. His feet were noted to rotate inward,
and he exhibited gross motor delays. Id. at 35–36.
The Sterlings continued to seek out further evaluation and treatment options in 2015. In
January of that year, they saw another ear, nose, and throat specialist, Matthew Kashima, M.D.
Ex. 7 at 4–5, filed Nov. 29, 2016 (ECF No. 13-5). The Sterlings reported concerns about A.S.
having ear pain, sound sensitivity, or deficits in his hearing and comprehension ability, as well as
possible seasonal allergies. Id. at 4. They had tried various treatments, including a hyperbaric
chamber and diet modifications. Id. Dr. Kashima prescribed nasal steroids. Id. at 5. Subsequently,
the Sterlings took A.S. to see Howard Kader, M.D., for a gastroenterology evaluation on
February 10, 2015. Ex. 5 at 4–9, filed Nov. 29, 2016 (ECF No. 13-3). Based on their report, Dr.
Kader recorded that A.S. “stooled normally as an infant until after his MMR was given,” after
which he was “found to have leuko[p]enia and evaluated in the ER and felt related to his 1 year
vaccination immune reaction.” Id. at 5. A.S. was noted to have many problems related to digestion
and bloating. Id. Dr. Kader discussed a wide range of possible diagnoses, including irritable
bowel syndrome, celiac disease, and pancreatic insufficiency, and he recommended lab tests and
a follow-up consultation. Id. at 8.
On March 23, 2015, A.S. saw Richard Layton, M.D. Ex. 14 at 38–42, filed Nov. 29, 2016
(ECF No. 14-3). Dr. Layton recorded five pages of handwritten notes from this initial visit,
providing a detailed assessment of A.S.’s condition largely consistent with what other records
reflect. See id. He described A.S.’s developmental delay and speech regression, stating that no
formal evaluation had been made to date on these concerns. Id. at 39. A.S.’s gastrointestinal
difficulties, food reactions, possible allergies, gait abnormalities, and more were all recorded in
4

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Dr. Layton’s notes. Id. at 38–42. Dr. Layton made no mention of encephalopathy or other brain
injury in the detailed notes from this initial consultation. See id. However, a billing statement
from this visit—which lists procedures and diagnoses along with their billing codes—contains a
check mark next to “encephalopathy.” Ex. 16 at 54–55, filed Nov. 29, 2016 (ECF No. 14-5).
The Sterlings prepared several documents in conjunction with their visits to Dr. Layton. A
self-reported medical history form4 included the following list of medical conditions:
speech/cognitive delay, food allergies, gait issues, and “possible Autism Spectrum Disorder
(ASD) (not diagnosed).” Ex. 16 at 57. A written summary5 of A.S.’s medical history, also
provided by the Sterlings, stated that, “[a]t his 2-year checkup, [A.S.]’s Pediatrician stated that
[A.S.] may have Autism if other factors weren’t ruled out.” Ex. 14 at 7. This self-reported history
also memorialized their view that A.S. “may have had a Vaccine Induced Autoimmune response,
which was further continually aggravated by additional vaccines and his diet at the time, resulting
in the progression of his ASD like symptoms.” Id. at 8. The Sterlings expressed the concern that
A.S. had experienced neurological inflammation or an encephalopathy. Id.
A.S. continued with physical, speech, and occupational therapy, and with visits to Dr.
Layton. See generally Ex. 2; 14; 16. Under Dr. Layton’s orders, A.S.’s hair was tested for the
presence of elements such as aluminum, copper, lead, and nickel. Ex. 16 at 18–22. Aside from
billing statements from Dr. Layton’s office, no medical records (from Dr. Layton or other
providers) support a diagnosis of encephalopathy for A.S.
II. Procedural History
After being filed in May 2016, the case was assigned to Chief Special Master Dorsey.
Following a January 12, 2017 status conference, the Chief Special Master issued an order in
which she noted her preliminary view that A.S. may have autism (a fact Petitioner had denied),
emphasized that claims of vaccine-caused ASDs have consistently been unsuccessful in the
Vaccine Program, and directed Petitioner to amend his petition so as to clearly identify A.S.’s
diagnosis. Order at 1, filed Jan. 13, 2017 (ECF No. 17). Petitioner filed his Amended Petition on
April 14, 2017, alleging injuries including neurologic neglect syndrome, expressive language
disorder, unspecified disorders of the nervous system, and immune dysfunction. Am. Pet. at 3.
Respondent filed his Rule 4(c) Report on June 2, 2017, arguing that A.S.’s medical records
suggested a diagnosis of autism, and requesting the claim’s dismissal. See generally Rule 4(c)
Rep.
The Chief Special Master subsequently conducted a status conference with the parties,
during which Petitioner conceded that A.S. had been diagnosed with autism. Order at 1, filed
Aug. 17, 2017 (ECF No. 28). She also cautioned Petitioner that “without a specific vaccine-
4 The medical history form does not bear a date.
5 The written summary also does not bear a date.
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related injury other than autism, this case lacks reasonable basis,” and warned that “unless
[P]etitioner can demonstrate from the medical records that A.S. suffered a vaccine-related injury
other than autism,” she would not reimburse attorney’s fees or costs, including expert costs. Id.
The following month, the Chief Special Master issued an order directing Petitioner to show cause
why his case should not be dismissed. Order to Show Cause, filed Sept. 25, 2017 (ECF No. 30).
The Order emphasized that “[P]etitioner and his counsel have been disingenuous with the court
about A.S.’s autism diagnosis,” as A.S. was diagnosed with regressive autism by Dr. Richard
Layton in 2015. Id. at 3.
Petitioner responded to the Show Cause Order with a status report on October 24, 2017.
ECF No. 31. Chief Special Master Dorsey thereafter issued an order addressing that status report,
in which she noted that Petitioner had again failed to identify A.S.’s specific diagnosis. Order,
filed Oct. 25, 2017 (ECF No. 33). While reiterating her prior warning that the case would lack a
reasonable basis unless Petitioner failed to demonstrate that A.S. suffers from a specific vaccine-
related injury other than autism, she nevertheless permitted the case to move forward. Id. at 2.
Petitioner subsequently filed reports from two experts on December 26, 2017: the first
from James Lyons-Weiler, Ph.D., and the second from Toni Bark, M.D. Respondent also filed
reports from two experts: one from Max Wiznitzer, M.D., and one from Jeffrey Johnson, Ph.D.
Following the filing of these expert reports, Chief Special Master Dorsey reassigned the
case to me on October 23, 2018. Order Reassigning Case (ECF No. 53). I held a status conference
with the parties on November 1, 2018, at which time I expressed similar concerns about the
claim’s viability based on my review of the record. I informed the parties of my intention to
resolve this matter based on written filings. See Order, filed Nov. 1, 2018 (ECF No. 55).
The parties filed briefs in support of their respective positions in the spring of 2019. See
generally Mem.; Opp.; Reply. Petitioner’s Memorandum was accompanied by a supplemental
report from Dr. Lyons-Weiler. This matter is now ripe for resolution.
III. Expert Reports
A. Petitioner’s Experts
1. Dr. Toni Bark
Petitioner filed one expert report from Toni Bark, M.D. See generally Ex. 31, filed Dec. 26,
2017 (ECF No. 37-2) (“Bark Rep.”). Dr. Bark’s curriculum vitae (“CV”) was not filed in this
case, but her report states that she received her B.S. from the University of Illinois and her M.D.
from Rush Medical College. Id. at 2. She completed a residency in pediatrics at the University of
Illinois in 1991, then held a “directorship” in the pediatric emergency room of Michael Reese
Hospital from December 1991 to May 1993. Id. She provided no subsequent details of her
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employment records, simply stating that she has a private practice which includes vaccine injury
patients. Id.
In her five-page report, Dr. Bark discusses A.S.’s medical history, highlighting the
temporal proximity between the vaccinations at his one-year well-child visit and his subsequent
viral illness and purported onset of developmental regression. Bark Rep. at 4. She accepts the
“diagnosis” of encephalopathy offered by Dr. Layton (found only in billing statements), making
no mention of a possible ASD diagnosis. Id.
Dr. Bark does not opine conclusively on the question of whether vaccines caused A.S.’s
illness. Bark Rep. at 4. Instead, she recommends genetic testing in order “to ascertain if issues
are genetic or epigenetically induced by vaccinations.” Id. Her explanation of how one or more
vaccines could have caused A.S.’s illness is both difficult to follow and relatively devoid of
citations to supportive medical literature. She points to vaccine adjuvants—in particular,
aluminum—as potentially harmful agents, particularly at the genetic level. Id. at 3. “The
deleterious effects of aluminum on gene activity can be compartmentalized to active chromatin
subfractions,” she writes, explaining that excessive aluminum levels can impair the ability of
RNA and DNA “to adequately read out genetic information.” Id. She also discusses the possibility
of excessive aluminum entering the brain, asserting that “injected aluminum is taken up by the
macrophages and can be carried into the brain causing chronic activation of the microglial cells.”
Id. She states also that “excessive oxidative damage” is possible, and could be confirmed by lab
tests that would show whether “aerobic respiration has been changed to anaerobic due to
mitochondrial damage.” Id. at 4. In support for her remarks, Dr. Bark references two pieces of
medical literature, neither of which was filed in this case. Id. at 5. She does not explain how either
article supports her stated positions. See generally id.
2. Dr. James Lyons-Weiler
James Lyons-Weiler, Ph.D., filed two reports on Petitioner’s behalf. See generally Ex. 27,
filed Dec. 26, 2017 (ECF No. 34-2) (“Lyons-Weiler First Rep.”); Ex. 67, filed Mar. 29, 2019
(ECF No. 62-2) (“Lyons-Weiler Second Rep.”). As reflected in his CV, Dr. Lyons-Weiler
received his B.A. from the State University of New York-Oswego, followed by a Master’s degree
in Zoology from the Ohio State University and a Ph.D. in ecology, evolution, and conservation
biology from the University of Nevada in Reno. Ex. 28 at 1, filed Dec. 26, 2017 (ECF No. 34-3)
(“Lyons-Weiler CV”). In his second report, he notes that he “helped create the field of
Bioinformatics.” Lyons-Weiler Second Rep. at 1.
Dr. Lyons-Weiler asserts that A.S. does not have autism, but rather has a vaccine-induced
encephalopathy, which led to a developmental coordination disorder (“DCD”) featuring sensory
motor deficits. Lyons-Weiler First Rep. at 1. He clarifies in his second report that the primary
injury, the alleged encephalopathy, occurred after A.S.’s one-year vaccinations (which he
received on January 9, 2013)—despite the fact that the Amended Petition points to the May 2013
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vaccinations as causal. Lyons-Weiler Second Rep. at 2. A claim based on an encephalopathic
reaction well before May 2013 would also be untimely under the Program’s three-year limitations
period. Section 16(a)(2). However, Dr. Lyons-Weiler also asserts that the subsequent
vaccinations A.S. received significantly aggravated his condition—though he does not specify
which vaccines the aggravation could be attributed to. Id.
In his two reports, Dr. Lyons-Weiler consistently reiterates that while he does not find tht
A.S. had autism, his proffered theory of causation involves “the very same processes known to
be involved in the development of autism.” Lyons-Weiler First Rep. at 5; see also Lyons-Weiler
Second Rep. at 3. This process, Dr. Lyons-Weiler explains, involves thimerosal and aluminum
present in vaccines. Lyons-Weiler First Rep. at 1, 3, 9. He offers a variety of mechanisms by
which these vaccine components could cause harm, either alone or in conjunction with other
factors. For example, he asserts that thimerosal inhibits the endoplasmic reticulum
aminopeptidase 1 protein, thereby inhibiting the adaptive immune system. Id. at 1–2. Thimerosal
and/or aluminum could cause “cellular immunological response dysfunction,” he states. Id. at 6.
For this reason, he points to A.S.’s hair testing results, which purportedly showed “slightly
increased” levels of aluminum, and concludes that these results “indicat[e] either high exposure
or metabolic failure of clearance, either of which is key evidence toward a finding of causality.”
Id. at 3.
In addition, Dr. Lyons-Weiler asserts that when children are given acetaminophen after
receiving the MMR vaccine (in order to avoid a vaccine-related fever), the acetaminophen causes
depletion of glutathione. Lyons-Weiler First Rep. at 5, 7. This glutathione depletion causes
excitotoxicity, which “mimic[s] concussive brain injury, leading to chronic microglial
activation.” Id. at 5. Based on A.S.’s family history, Dr. Lyons-Weiler asserts that A.S. is
predisposed to autoimmunity, and he concludes that one or more of the mechanisms he outlined
would cause an encephalopathy, leading to developmental coordination disorder. Id. at 9. And as
clarified in his second report, he identifies A.S.’s one-year vaccines as the most likely injurious
ones, and postulates that this condition was significantly aggravated by “subsequent vaccinations
that were within the 3-year window.” Lyons-Weiler Second Rep. at 2.
B. Respondent’s Experts
1. Dr. Max Wiznitzer
Max Wiznitzer, M.D., provided one written report on Respondent’s behalf. Ex. A, filed
Sept. 14, 2018 (ECF No. 51-1) (“Wiznitzer Rep.”). Dr. Wiznitzer graduated from the honors
program in medical education at Northwestern University, where he received a B.S. in medicine
in 1975, followed by his M.D. in 1977. Ex. B at 1, filed Sept. 14, 2018 (ECF No. 51-13) He
completed a three-year internship and residency in pediatrics at Cincinnati Children's Hospital,
followed by a one-year fellowship in child development and developmental disorders at the
Cincinnati Center for Developmental Disorders. Id. He also completed a three-year child
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neurology fellowship at the University of Pennsylvania and Children’s Hospital of Philadelphia,
followed by a two-year National Institute of Health fellowship in disorders of higher cortical
function in children at the Albert Einstein College of Medicine in the Bronx, New York (which
involved working with children with ASDs). Id. Dr. Wiznitzer currently works as a professor of
neurology at Case Western Reserve University, and as a pediatric neurologist at the University
Hospitals of Cleveland in Cleveland, Ohio. Id. at 2. Dr. Wiznitzer holds board certifications in
pediatrics and neurology. Id. at 5.
Much of Dr. Wiznitzer’s twenty-nine-page report is dedicated to reviewing A.S.’s
medical history, as well as the statements offered by Petitioner’s experts. He disputes several key
points made by Dr. Lyons-Weiler. First, he disagrees with Dr. Lyons-Weiler’s characterization
of A.S.’s condition. Wiznitzer Rep. at 19–20. While Dr. Lyons-Weiler asserts that A.S. has a
DCD, Dr. Wiznitzer finds this diagnosis to be incorrect, as DCDs involve only motor deficits,
and do not encompass the social, language, and attention deficits that A.S. has. Wiznitzer Rep. at
19. And while Dr. Lyons-Weiler believes A.S. cannot have autism because he lacks an intellectual
disability, Dr. Wiznitzer points out that intellectual disability is not, in fact, a diagnostic criterion
for ASDs. Id. at 20. Dr. Wiznitzer also disputes the plausibility of the causation theories put forth
by Petitioner’s experts. Id. at 19–21, 24–25. He explains that the proffered theories are
unsupported by the cited literature. Id. at 21–24. Regardless of whether A.S. has autism or another
unspecified neurodevelopmental disorder, Dr. Wiznitzer concludes that his condition was neither
caused nor aggravated by any vaccine. Id. at 25.
2. Dr. Jeffrey Johnson
Jeffrey Johnson, Ph.D., provided one written report in support of Respondent’s position.
See generally Ex. C, filed Sept. 14, 2018 (ECF No. 52-1) (“Johnson Rep.”). He opined that the
literature cited by Dr. Lyons-Weiler uniformly did not provide support for his conclusions. See
generally id.
As outlined in his report, Dr. Johnson received his B.S. in biology and M.S. in
pharmacology from the University of Minnesota-Duluth. Johnson Rep. at 1. He received his
Ph.D. in molecular and environmental toxicology from the University of Wisconsin-Madison. Id.
He has served as a professor of pharmaceutical sciences and pharmacology—first at the
University of Kansas Medical Center, and subsequently at the University of Wisconsin—since
1995. Id. Dr. Johnson performs research in the fields of neuroprotection, neuropharmacology,
and neurotoxicology. Id.
In his thirteen-page report, Dr. Johnson walks through each piece of scientific literature
cited by Dr. Lyons-Weiler and explains why it does not provide meaningful support for his
opinions. Johnson Rep. at 4–12. For example, while Dr. Lyons-Weiler states that the presence of
thimerosal in vaccines causes harm by preventing proteins that protect against infectious agents
from being “properly trimmed,” which causes disruption of “everyday immunological signaling,”
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The very paper Dr. Lyons-Weiler cites in support for this contention includes a statement from
the authors indicating that “the low dose of thimerosal in vaccines would preclude any systemic
event.” Id. at 4–5 (discussing Lyons-Weiler First Rep. at 2; A. Stamogiannos, et al., Screening
Identifies Thimerosal as a Selective Inhibitor of Endoplasmic Reticulum Aminopeptidase, 1 ACS
Med. Chemistry Letters 681, filed as Ex. 44 (ECF No. 58-5) (emphasis added)). In total, Dr.
Johnson discusses twenty-two items of literature, explaining why each one does not support Dr.
Lyons-Weiler’s conclusions. Id. at 4–12.
IV. Parties’ Respective Arguments
A. Petitioner
In both his initial Memorandum and his Reply brief, Petitioner offers no legal argument in
support of his position that he is entitled to a compensation award. See generally Mem.; Reply.
Instead, both filings contain numerous paragraphs taken directly from Dr. Lyons-Weiler’s first
report. See, e.g., Mem. at 7; Reply at 8 (repeating verbatim entire paragraph found on page 9 of
Lyons-Weiler First Rep.).
After restating several of Dr. Lyons-Weiler’s various arguments in support of vaccine
causation, Petitioner argues that A.S. does not have a “classical ASD diagnosis,” but that even if
he does have an ASD, this should not preclude a finding of entitlement. Mem. at 8. He argues
further that Respondent has offered no alternative cause to A.S.’s injuries other than that he has
autism. Id. Finally, he asserts conclusorily that he has satisfied the causation-in-fact test
established by the Federal Circuit in Althen v. Secretary of Health & Human Services, 418 F.3d
1274 (Fed. Cir. 2005). Id.
In his Reply, Petitioner argues that Respondent’s opposition brief consists of nothing more
than “inappropriate and unhelpful” ad hominem attacks on Petitioner’s experts. Reply at 1.
Petitioner also reiterates that, even if A.S. has an ASD, this should not automatically disqualify
him from entitlement to compensation under Vaccine Program precedent. Id. at 1–2. Following
the first three paragraphs, the Reply brief is identical to Petitioner’s initial Memorandum. See
generally Mem.; Reply.
B. Respondent
In his brief arguing against an award of compensation, Respondent preliminarily
maintains that A.S. did not experience an encephalopathy, and that his injury should not be
characterized as such. Opp. at 5–9. He argues that Petitioner’s experts are not qualified to opine
on A.S.’s correct diagnosis (or on the question of vaccine causation). Id. at 5–6. Similarly,
Respondent points out that Dr. Layton is not a specialist in pediatric neurology or
neurodevelopment, thus rendering his opinion less persuasive. Id. at 8. Moreover, even within
Dr. Layton’s records, the encephalopathy “diagnosis” appears only in billing statements, not in
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actual records or notes from A.S.’s visits with Dr. Layton. Id. Respondent asserts that Petitioner
likely seeks to rely on this billing notation (which is not itself a diagnosis) to circumvent
comparison to the Omnibus Autism Proceeding (“OAP”) cases, a technique which has been
repeatedly attempted without success by Program claimants alleging claims of ASD-like
developmental regression and delay. Id. at 9 (citing seven Vaccine Program cases involving ASD
claims characterized as encephalopathy or other injury).
Turning to the question of causation-in-fact, Respondent argues that Petitioner has failed
to satisfy all three Althen prongs. First, he asserts that the theory offered by Dr. Lyons-Weiler is
“meandering” and “incoherent,” but to the extent that it can be understood, it is not scientifically
sound. Opp. at 10. Several central elements of the theory—including whether thimerosal and
aluminum adjuvants can cause adverse neurological effects, and the role of mitochondrial
dysfunction—have been rejected in many past Program decisions. Id. at 10–11. Moreover, as
explained in great detail by Respondent’s experts, the literature cited by Dr. Lyons-Weiler does
not support his position. Id. at 11 (citing Wiznitzer Rep. at 21–24; Johnson Rep. at 4–11). For
these reasons, Respondent argues that Petitioner has not satisfied the first Althen prong by
providing a reliable scientific theory of causation. Id.
Despite the deficiencies in Petitioner’s proffered theory of causation, Respondent argues
that A.S.’s documented clinical course does not include evidence of the various processes that
would be expected under such a theory. Opp. at 12–13. For example, testing performed on A.S.
did not reveal elevated levels of metal in his body, contrary to the assertions of Petitioner’s
experts—thus greatly undermining the assertion that A.S. was experiencing some kind of toxic
process. Id. Therefore, Respondent argues that Petitioner has failed to satisfy the second Althen
prong. And finally, Respondent argues that A.S.’s neurologic problems did not begin within a
medically-acceptable timeframe after vaccination. Id. at 15. Medical records preponderantly
show that his problems began more than six months after the May 2013 vaccinations, which
Petitioner has not demonstrated to be a reasonable time frame to attribute causation to any of the
vaccinations at issue. Id. Thus, Petitioner cannot satisfy the third Althen prong.
ANALYSIS6
At the outset, the question of how best to characterize A.S.’s condition must be resolved.
Petitioner and his experts have alleged different injuries (or aggravation thereof) at various points
in this case’s history. In his Amended Petition, Petitioner asserts that A.S. suffers vaccine-caused
6 In most entitlement decisions, I would typically include a full recitation of the legal standards applicable to a Program
claim under the Federal Circuit’s Althen test. See, e.g., R.V. v. Sec’y of Health & Human Servs., No. 08-504V, 2016
WL 3882519, at *28–32 (Fed. Cl. Spec. Mstr. Feb. 19, 2016), mot. for review denied, 127 Fed. Cl. 136 (2016). Here,
however, in the interests of brevity, and because the claim asserts autism as an injury (a subject that has been litigated
over and over again in the Program), I do not do so.
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neurologic neglect syndrome, expressive language disorder, unspecified disorders of the nervous
system, and immune dysfunction. Am. Pet. at 3. Dr. Bark accepts the “diagnosis” of
encephalopathy offered by Dr. Layton. Bark Rep. at 4. Dr. Lyons-Weiler, whose expert reports
form the basis for both of Petitioner’s briefs in support of compensation, asserts that A.S.
experienced a vaccine-induced encephalopathy shortly following his (statute of limitations-barred)
January 9, 2013 vaccinations, leading to a DCD featuring sensory motor deficits. Lyons-Weiler
First Rep. at 1. Dr. Lyons-Weiler also states that subsequent vaccinations significantly aggravated
this condition—although his proffered theory focuses more on the question of causation than
aggravation. Lyons-Weiler Second Rep. at 2; see generally Lyons-Weiler First Rep. Respondent,
by contrast, argues that A.S.’s condition is best characterized as an ASD or similar developmental
delay or neurologic condition. Opp. at 9.
The assorted conditions alleged in the Amended Petition—neurologic neglect syndrome,
expressive language disorder, nervous system dysfunction, and immune dysfunction—appear to
have been cherry-picked from differential diagnoses considered throughout A.S.’s various
appointments with medical professionals as they attempted to find an explanation for his condition.
See, e.g., Ex. 2 at 26 (Dr. Clayville initially assessing A.S.’s developmental delay as expressive
language disorder or possible ASD); Ex. 11 at 28 (occupational therapist characterizing A.S.’s
condition as neurologic neglect syndrome). Neither party’s experts discuss these various
conditions as discrete entities, each of which was caused or aggravated by a vaccine. Instead, both
of Petitioner’s experts describe A.S. as having some form of brain injury or neurologic problem
that would account for his overall condition. Consistent with these assessments, I will consider
A.S.’s condition as a whole, not as a constellation of discrete diagnoses.
In light of the fact that A.S. has not undergone a formal ASD evaluation, I cannot
definitively resolve, based on the medical record, the question of whether his neurologic condition
is best considered an ASD (although the evidence in favor of that conclusion is fairly strong
nonetheless). At a minimum, however, the medical records and both parties’ expert reports do
preponderantly establish that A.S. suffers from some form of neurologic condition resulting in
developmental delay. This leads to the primary question at issue: whether A.S. experienced an
encephalopathy any time in the first half of 2013 (whether after the January or May vaccinations)
that could have precipitated it. Having reviewed the record, I find that whether the claim is
construed as a Table or non-Table claim, Petitioner has not preponderantly established evidence
of any post-vaccination encephalopathy.7
7 To receive compensation under 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 a vaccine identified on the Table
that the petitioner or injured party received, or (2) that he suffered an injury that was actually caused by a vaccine. See
§§ 11(c)(1), 13(a)(1)(A). Petitioner has not pled his claim as arising from the Vaccine Table, but he does allege that
A.S. experienced an encephalopathy. I include discussion of the Table definition of encephalopathy for purposes of
analysis.
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First, an examination of the record does not uncover any evidence that A.S. likely suffered
an encephalopathy as defined by the Table after receipt of the DTaP vaccine (the only one A.S.
received that could be the basis for such a claim).8 See 42 C.F.R. § 100.3(a)(II)(B) (2018). To
succeed, a petitioner would need to establish both that the injured party experienced an “acute”
encephalopathy—typically evidenced by a decreased change in consciousness (as that term is
defined in the Qualifications and Aids to Interpretation, 42 C.F.R. § 100.3(c)(2) (2018)) of
sufficient severity to warrant hospitalization—and that the encephalopathy subsequently became
“chronic” (that is, it lasted for at least six months). Thompson v. Sec’y of Health & Human Servs.,
No. 15-1498V, 2017 WL 2926614, at *7–8 (Fed. Cl. Spec. Mstr. May 16, 2017). Here, however,
there is no evidence that A.S. suffered an encephalopathy shortly after vaccination, nor at any time
thereafter. The medical records filed in this case do not establish that A.S. experienced any kind
of reaction within seventy-two hours of the May 7, 2013 vaccinations, or in a similar timeframe
after the January vaccinations. At A.S.’s subsequent checkup with Dr. Clayville on July 26th, the
Sterlings still reported no post-vaccination reaction or other sign of an encephalopathy. Ex. 2 at
38–43.
Second, Petitioner is unable on this record to establish a non-Table encephalopathy.
Although a causation-in-fact claim alleging encephalopathy is not subject to the Table’s stringent
defined requirements, it still must be supported by preponderant proof, and must establish more
than a neurologically-derived symptom. Specific symptoms that would suggest an individual had
experienced an encephalopathy include crying, insomnia, fever, moodiness, and irritability. Cook
v. Sec’y of Health & Human Servs., No. 00-331V, 2005 WL 2659086, at *14 (Fed. Cl. Spec. Mstr.
Sept. 21, 2005); Noel v. Sec’y of Health & Human Servs., No. 99-538V, 2004 WL 3049764, at *17
(Fed. Cl. Spec. Mstr. Dec. 14, 2004). But in this case, the first evidence of A.S.’s developmental
delay was not recorded until January 27, 2014, more than eight months after the May 7, 2013
vaccinations. Id. at 21–26. And these symptoms (which Dr. Clayville initially characterized as an
expressive language delay and possible ASD) cannot persuasively be pointed to as proof of
“encephalopathy”—they are at most sequelae of an alleged encephalopathy, and therefore it is
circular reasoning to propose that they prove A.S. also experienced an encephalopathy in the first
place. See R.V. v. Sec’y of Health & Human Servs., No. 08-504V, 2016 WL 3882519, at *34 n.80
(Fed. Cl. Spec. Mstr. Feb. 19, 2016), mot. for review denied, 127 Fed. Cl. 136 (2016).
The only records supporting a diagnosis of encephalopathy are found in Dr. Layton’s billing
statements, but these fleeting references are unsupported even by Dr. Layton’s own records from
his visits with A.S. Compare Ex. 16 at 54–55 (billing statement with check mark next to
“encephalopathy”) with Ex. 16 at 3–21 (Dr. Layton’s notes from several visits with A.S., making
no mention of encephalopathy). With such weak support for the injury alleged, Petitioner’s claim
8 Encephalopathy following the pneumococcal or Hib vaccine (the other two vaccines A.S. received on May 7, 2013)
is not recognized as a Vaccine Table injury. See generally 42 C.F.R. § 100.3(a) (2018).
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of post-vaccination encephalopathy—Table or non-Table—cannot succeed.
Petitioner’s other non-Table claim, alleging causation-in-fact or significant aggravation of
some other neurologic condition—whether DCD or an ASD—fares no better. In discussing his
proffered theory of vaccine causation in this case, Dr. Lyons-Weiler straightforwardly admits that
he relies on “the very same processes known to be involved in the development of autism.” Lyons-
Weiler First Rep. at 5. My reasoning in this case is therefore properly influenced by the many prior
Vaccine Program cases involving allegations of vaccine-caused ASD-like disorders. The decisions
from those cases overwhelmingly suggest that vaccines do not cause ASDs or conditions with
comparable neurologic sequelae.
Several years ago, more than 5,400 cases were initially filed under short form petition in the
OAP, where thousands of petitioners’ claims that certain vaccines caused autism were joined for
purposes of efficient resolution. A “Petitioners’ Steering Committee” was formed by many
attorneys who represent Vaccine Program petitioners, with about 180 attorneys participating. This
group chose “test” cases to represent the entire docket, with the understanding that the outcomes
in these cases would be applied to cases with similar facts alleging similar theories.
The Petitioners’ Steering Committee chose six test cases to present two different theories
regarding autism causation. The first theory alleged that the measles portion of the measles,
mumps, rubella (“MMR”) vaccine precipitated autism, or, in the alternative, that MMR plus
thimerosal-containing vaccines caused autism, while the second theory alleged that the mercury
contained in thimerosal-containing vaccines could affect an infant’s brain, leading to autism.
The first theory was rejected in three test case decisions, all of which were subsequently
affirmed. See generally Cedillo v. Sec’y of Health & Human Servs., No. 98-916V, 2009 WL
331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot. for review denied, 89 Fed. Cl. 158 (2009), aff’d,
617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y of Health & Human Servs., No. 03-654V,
2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), mot. for review denied, 88 Fed. Cl. 473
(2009), aff’d, 605 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y of Health & Human Servs., No. 01-
162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009).
The second theory was similarly rejected. Dwyer v. Sec’y of Health & Human Servs., No.
03-1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec’y of Health &
Human Servs., No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v.
Sec’y of Health & Human Servs., No. 03-215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12,
2010).
Ultimately, a total of eleven lengthy decisions by special masters, the judges of the U.S.
Court of Federal Claims, and the panels of the U.S. Court of Appeals for the Federal Circuit
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unanimously rejected petitioners’ claims. These decisions found no persuasive evidence that the
MMR vaccine or thimerosal-containing vaccines caused autism. The OAP proceedings concluded
in 2010.
Nothing about this case distinguishes it from either the OAP determinations, or the
numerous subsequent cases that attempted unsuccessfully to establish a causation theory that was
purportedly different from what had been litigated in the OAP. See, e.g., Rogero v. Sec’y of Health
& Human Servs., No. 11-770V, 2017 WL 4277580, at *4–5 (citing eighteen unsuccessful post-
OAP autism claims that went to hearing and thirteen post-OAP autism claims that were rejected
without a hearing), mot. for review denied, slip op. (Fed. Cl. Jan. 11, 2018), aff’d, 748 F. App’x
996 (Fed. Cir. 2018).
The rare cases in which a claimant succeeded in establishing a vaccine-caused
encephalopathy that produced developmental regression or ASD-like symptoms were Table
claims, and they underscore the importance of immediate evidence of acute encephalopathy
precipitated by a close-in-time vaccination. See Wright v. Sec’y of Health & Human Servs., No.
12-423V, 2015 WL 6665600, at *10 (Fed. Cl. Spec. Mstr. Sept. 21, 2015) (child with ASD-type
symptoms experienced a Table encephalopathy; noting that he convulsed and vomited during car
ride home after receiving vaccinations (possibly evincing a brief seizure), then became listless,
unresponsive, and “basically catatonic” by the following day); Bast v. Sec’y of Health & Human
Servs., No. 01-565V, 2012 WL 6858040, at *35–36 (Fed. Cl. Spec. Mstr. Dec. 20, 2012)
(discussing case report about Hannah Poling, a successful Vaccine Program claimant who alleged
a Table encephalopathy claim for her autism-type symptoms; noting that Hannah developed a high
fever, inconsolable crying, irritability, and lethargy, and refusal to walk within forty-eight hours
after vaccination), appeal dismissed sub nom. M.S.B. ex rel. Bast v. Sec’y of Health & Human
Servs., 579 F. App’x 1001 (Fed. Cir. 2014). Outside these narrow circumstances, the Court of
Federal Claims has made it clear that petitioners cannot successfully recast a claim that a vaccine
caused autism into an encephalopathy claim, based on the logic that the neurologic symptoms
associated with an ASD reflect an underlying brain injury. See, e.g., Cunningham v. Sec’y of
Health & Human Servs., No. 13–483V, 2017 WL 1174448, at *5 (Fed. Cl. Jan. 25, 2017).
Ultimately, Petitioner’s causation theory is fundamentally at odds with the sound reasoning
found in so many well-reasoned Vaccine Program decisions. The weaknesses of this theory are
further underscored by several factors. As explained persuasively by Dr. Johnson, the literature
cited by Dr. Lyons-Weiler does not support his stated positions. See Johnson Rep. at 4–12. The
meandering, confusing nature of Dr. Lyons-Weiler’s reports, as well as his apparent disregard for
well-accepted scientific principles, further weakens the credibility of his assertions. See, e.g.,
Lyons-Weiler Second Rep. at 2 (accusing studies on vaccines and autism of data manipulation and
fraud). In addition, and more fundamentally, Dr. Lyons-Weiler appears to be wholly unqualified
to opine on the question of vaccine causation. His academic training centered on zoology and
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ecology, not medicine or immunology, and he does not appear to have performed research or
published peer-reviewed work on any subject relevant to the present matter. See generally Lyons-
Weiler CV.
Conclusion
As noted above, over two years ago the chief special master (to whom the case was
previously assigned) expressed the preliminary view that Petitioner’s claim likely lacked
reasonable basis. Nothing I have seen presented in Petitioner’s arguments or expert reports leads
me to reach a contrary conclusion—and such a reasonable basis deficiency underscores the
rationale for the claim’s dismissal.
As other decisions have observed, reasonable basis (a concept applied most commonly when
evaluating if an attorney’s work on an unsuccessful case should be compensated) is a lesser
standard than the preponderance standard governing Vaccine Act claims, and looks to see if any
objective proof exists that would render the claim feasible, even if its chances of success are low.
See Braun v. Sec’y of Health & Human Servs., No. 17-1571V, 2019 WL 3228040, at *4 (Fed. Cl.
2019) (citing Austin v. Sec’y of Health & Human Servs., No. 10-362V, 2013 WL 659574 (Fed. Cl.
Spec. Mstr. Jan. 31, 2013)). Thus, a claim that is dismissed for failing to meet the preponderant
standard may still be supported by sufficient objective proof for a fees award (and hence possess
reasonable basis). A claim lacking in reasonable basis, however, has virtually no chance of meeting
the preponderance test.
Here, there is an extensive body of law discussing claims involving ASDs or developmental
symptoms alleged to have occurred due to vaccination—and that caselaw (which existed at the
time of this case’s initiation) overwhelmingly establishes that such claims are almost never
meritorious. As a result, a claim like this one (where there is virtually no evidence of an
encephalopathy—the one objective finding that has been the basis for success in exceedingly rare
instances) was not just unlikely to succeed; rather, it lacked sufficient objective proof for its
assertion at all. My experience and reasoned judgment in adjudicating vaccine claims involving
ASDs and similar neurodevelopmental disorders strongly informs my conclusion not only that this
claim could not succeed where countless others failed, but that it lacks the foundational objective
support for its assertion in the first place. Because Petitioner has not—despite due opportunity—
shown otherwise, I must DISMISS his claim.
In the absence of a timely-filed motion for review (see Appendix B to the Rules of the
Court), the Clerk SHALL ENTER JUDGMENT in accordance with this decision.9
9 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by filing a joint notice renouncing their
right to seek review.
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s/Brian H. Corcoran
Brian H. Corcoran
Special Master
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