VICP Registry Case Source Bundle
Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_19-vv-00350
Package ID: USCOURTS-cofc-1_19-vv-00350
Petitioner: R.M.
Filed: 2019-03-07
Decided: 2024-05-10
Vaccine: MMR
Vaccination date: 2016-03-09
Condition: transverse myelitis
Outcome: dismissed
Award amount USD: 

AI-assisted case summary:
On March 7, 2019, David McBane, on behalf of R.M., a minor, filed a petition for compensation under the National Vaccine Injury Compensation Program. The petition alleged that R.M. developed transverse myelitis as a result of receiving the DTaP-IPV (Kinrix) vaccine and the MMRV (ProQuad) vaccine on March 9, 2016. Petitioner's counsel was Mark T. Sadaka. Respondent was the Secretary of Health and Human Services, represented by Meghan Murphy. Special Master Thomas L. Gowen presided over the case. Petitioner's expert, Dr. Alberto Martinez-Arizala, proposed a theory of molecular mimicry, suggesting that the vaccines triggered an autoimmune response leading to transverse myelitis. Dr. Martinez-Arizala opined that an onset of symptoms approximately 67 days after vaccination was medically acceptable, citing various case reports and studies. Respondent's expert, Dr. Timothy E. Lotze, agreed that R.M. had transverse myelitis but disagreed that it was related to the vaccinations, stating the onset was 9 weeks and 6 days after vaccination, which he considered too long to establish causation. Dr. Lotze also noted that the Institute of Medicine had concluded that evidence is insufficient to link these vaccines to transverse myelitis. The medical records indicated that R.M. was first taken to the emergency department on May 16, 2016, presenting with leg pain and inability to bear weight, progressing to flaccid paralysis. An MRI confirmed transverse myelitis. The medical records indicated R.M. was last seen walking on the evening of May 16, 2016, prior to his emergency room visit. This timeline was noted to be somewhat inconsistent with the affidavit provided by R.M.'s mother, Ms. Brenlee McBane, regarding the events leading up to his symptoms. The Special Master found that while the theory of molecular mimicry was accepted, the petitioner failed to establish a proximate temporal relationship between the vaccination and the onset of R.M.'s transverse myelitis. The medical literature cited by the petitioner for a 67-day onset was found unpersuasive, as it either referenced different vaccines or showed much shorter onset times for the vaccines R.M. received. The Special Master concluded that the petitioner had not provided preponderant evidence to satisfy the third prong of the Althen test. Therefore, R.M.'s petition was dismissed. The decision was issued on May 10, 2024.

Theory of causation field:
Petitioner alleged that R.M., a 4-year-old, received DTaP-IPV (Kinrix) and MMRV (ProQuad) vaccines on March 9, 2016, and subsequently developed transverse myelitis approximately 67 days later. Petitioner's expert, Dr. Alberto Martinez-Arizala, proposed a theory of molecular mimicry, suggesting the vaccines triggered an autoimmune response. Dr. Martinez-Arizala opined that the 67-day onset was medically acceptable, citing literature with varying onset times, including some referencing hepatitis B vaccines and others with shorter intervals for DTP/MMR. Respondent's expert, Dr. Timothy E. Lotze, disagreed with the temporal relationship, stating the 9-week, 6-day interval was too long and citing the Institute of Medicine's conclusion of insufficient evidence. The Special Master, Thomas L. Gowen, accepted the theory of molecular mimicry but found the petitioner failed to establish a proximate temporal relationship, as the cited literature for a 67-day onset was not persuasive for the vaccines R.M. received, and other literature indicated much shorter onset times. The medical records indicated R.M. was last seen walking on May 16, 2016, the day he presented to the ER. The petition was dismissed on May 10, 2024, for failure to satisfy the third Althen prong. Attorneys involved were Mark T. Sadaka for petitioner and Meghan Murphy for respondent. The case was an off-Table injury claim.

Public staged source text:

================================================================================
DOCUMENT 1: USCOURTS-cofc-1_19-vv-00350-0
Date issued/filed: 2024-05-10
Pages: 11
Docket text: PUBLIC DECISION (Originally filed: 04/08/2024) regarding 61 DECISION of Special Master. Signed by Special Master Thomas L. Gowen. (hs) Service on parties made.
--------------------------------------------------------------------------------
Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 1 of 11
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
Filed: April 8, 2024
* * * * * * * * * * * * *
DAVID MCBANE, on behalf of R.M., *
*
*
Petitioner, * No. 19-350V
*
v. * Special Master Gowen
*
SECRETARY OF HEALTH *
AND HUMAN SERVICES, *
*
Respondent. *
* * * * * * * * * * * * *
Mark T. Sadaka, Law Offices of Sadaka Associates, LLC, Englewood, NJ, for petitioner.
Meghan Murphy, U.S. Dept. of Justice, Washington, D.C., for respondent.
DISMISSAL DECISION1
On March 7, 2019, David McBane, on behalf of R.M. (“petitioner”), filed a petition for
compensation in the National Vaccine Injury Compensation Program.2 Petition (ECF No. 1).
Petitioner alleged that as a result of R.M. receiving the diphtheria-tetanus-acellular pertussis,
inactivated polio vaccine (“Kinrix”) and the measles-mumps-rubella (“MMR”) and varicella
(“ProQuad”) vaccine on March 9, 2019, he developed transverse myelitis. Id. After a review of
the evidence filed in this matter, I find that petitioner has not established that he is entitled to
compensation, and therefore, the petition shall be dismissed.
1 Pursuant to the E-Government Act of 2002, see 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion
of Electronic Government Services because this opinion contains a reasoned explanation for the action in this
case, I intend to post it on the website of the United States Court of Federal Claims. The Court’s website is at
http://www.uscfc.uscourts.gov/aggregator/sources/7. Before the opinion is posted on the Court’s website, each party
has 14 days to file a motion requesting 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). An objecting party must provide the Court with a proposed redacted version of the opinion. Id. If
neither party files a motion for redaction within 14 days, the opinion will be posted on the Court’s website
without any changes. Id.
2 The National Vaccine Injury Compensation Program is set forth in Part 2 of the National Childhood Vaccine
Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755, codified as amended, 42 U.S.C. §§ 300aa-10 to 34 (2012)
(hereinafter “Vaccine Act” or “the Act”). Hereinafter, individual section references will be to 42 U.S.C. § 300aa of
the Act.

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 2 of 11
I. Procedural History
To accompany the petition, petitioner filed medical records to support his claim. See
Pet’r Exs. 1-11. After a review of the medical records, respondent file the Rule 4(c) report,
recommending against compensation. Resp. Report (“Rept.”) (ECF No. 31). In the Rule 4(c)
report, respondent did not deny that R.M. suffered from transverse myelitis, however, respondent
asserted that petitioner failed to provide any evidence to satisfy any of the Althen prongs, and
therefore, compensation should be denied. Id. at 5-8.
In response, petitioner filed an expert report from Alberto Martinez-Arizala, M.D., a
neurologist. Pet’r Ex. 16 (ECF No. 46). Petitioner also filed medical literature to accompany
Dr. Martinez-Arizala’s report. Pet’r Exs. 18-25 (ECF No. 47). Respondent filed an expert report
from Timothy E. Lotze, M.D. Resp. Ex. A (ECF No. 50).
The undersigned held a status conference on October 17, 2023. Rule 5 Order (ECF No.
52). During the status conference, I explained that the onset of R.M.’s transverse myelitis,
occurring approximately 67 or 68 days after the administration of the vaccines he received on
March 9, 2016, makes it difficult to prove Althen prong three. Id. at 2. Petitioner’s counsel was
given thirty days to file additional evidence to demonstrate that R.M.’s symptoms began closer in
time to vaccine administration.
On November 20, 2023, petitioner filed a status report requesting additional time to file
additional evidence to support onset and I granted petitioner an additional thirty days to file
supporting evidence. Pet’r Status Rept. (ECF No. 53). On December 21, 2023, petitioner again
requested an additional sixty days to file additional evidence to support onset and to show an
appropriate temporal relationship between the vaccine and the onset of R.M.’s symptoms. Pet’r
Status Rept. (ECF No. 55). After failing to file additional evidence by February 20, 2024,
petitioner filed a motion for an extension of time to March 20, 2024 to file additional evidence
supporting an appropriate timeframe between vaccine administration and onset of R.M.’s
symptoms. Pet’r Motion for Extension of Time (ECF No. 56). In the motion for an extension of
time, counsel stated that he had been unable to speak to petitioner or his family regarding
additional evidence and requested an additional thirty days to file additional evidence regarding
onset. Id. at 1.
In response to petitioner’s motion, observing that it had been 92 days since petitioner was
first ordered to file additional evidence supporting onset to show an appropriate temporal
relationship between the vaccine and the beginning of R.M.’s condition, I issued an Order to
Show Cause. Order to Show Cause (ECF No. 57). The Order to Show Cause again gave
petitioner an additional thirty days, until March 25, 2024 to file evidence to support an
appropriate temporal relationship between the vaccine and R.M.’s condition. Id.
Petitioner filed a supplemental expert report from Dr. Martinez-Arizala and four
additional medical articles in response to the Order to Show Cause. Pet’r Exs. 43-47 (ECF No.
58). Additionally, petitioner filed a response to the Order to Show Cause, stating that counsel
2

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 3 of 11
called petitioner and his wife 12 times, mailed them copies of the Rule 5 Order and the Order to
Show Cause, and sent six e-mails indicating that additional evidence was needed or the case
would be dismissed. Pet’r Response to Order to Show Cause (ECF No. 59). The response
acknowledges that no additional evidence has been provided, but that there is sufficient evidence
filed by petitioner to make a ruling based on the evidence filed to-date. Id. at 3.
Accordingly, this matter is now ripe for adjudication.
II. Relevant evidence
a. Medical records
R.M. received the DTap-IPV and MMR vaccines on March 9, 2016. Pet’r Ex. 1 at 49-50.
The first medical record after R.M.’s vaccination was on May 16, 2016, when he was taken to
the emergency department of St. Vincent Medical Center for an evaluation of leg pain and being
unable to put weight on his left leg. Pet’r Ex. 3 at 2. R.M. was discharged from the emergency
room, but a note indicated that “it was difficult to perform a formal neurologic exam because
[R.M.] was so sleepy.” Id. The following day, on March 17, 2016, R.M. was taken to Oregon
Health & Science University where he was initially discharged after R.M.’s abdominal pain had
resolved. Pet’r Ex. 2 at 145. However, R.M.’s mother returned almost immediately to the ER,
stating that R.M. vomited again in the car and stating that he could not feel his feet. Id. Dr.
Robert Cloutier wrote:
Patient refused to stand and appeared to have flaccid paralysis below the hips. Upon further
interview, I learned the last time the mother had actually seen the patient walking was
approximately 6:30 yesterday evening. The mother denies any trauma and denies any
evidence of unsteady gait or ataxia prior to 6:30…..Following my exam, I noted patient was
completely insensate at the level of approximately T12. Patient is areflexic with no deep
tendon reflexes at the level of the patella or Achilles….An emergent MRI was arranged of
the total spine with a differential diagnosis to include transverse myelitis versus Guillain-
Barré syndrome versus ADEM.
Pet’r Ex. 2 at 145. R.M. was then admitted to the hospital for additional care. R.M. had a spinal
MRI which revealed a “long segment of smooth moderate cord expansion from the level of T9 to
the conus with extensive T2 hyper intensity, more intense in the central portion of the cord.
Findings most likely represent transverse myelitis.” Id. at 28. The pediatric neurology consult
note written by Dr. Allison Empey on May 17, 2016 stated:
[R.M.] is a 4-year 3 month previously healthy male with acute onset lower extremity
paraplegia. Was in his usual state of health until Monday evening. Mom walked with
[R.M.] to get a slurpee at 7-11 around 6:30 pm. He was walking fine. Went home and he
was laying on mom’s bed playing with her phone. She took her phone away to answer
the phone and he started whining and slid off the bed….Mom picked him up and put him
back on the bed…She then left the room and then when went back into the room he was
on the floor again. She did not see if he fell or if he tried to walk and fell. Seemed to
3

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 4 of 11
be clutching at his lower abdomen/suprapubic area. When he was crying for 30 minutes,
mom took him to ED at St. Vincent. While he was there he complained of abdominal
pain. Was discharged. However, worsening pain so returned to DCH ED. Was
evaluated for abdominal pain, but when [R.M.]...stood up to be discharged noted to have
paralysis.
Pet’r Ex. 2 at 26. R.M. was treated with high dose steroids for 5 days. Id. R.M. was discharged
on May 26, 2016, however, he was unable to use his lower limbs and had absent sensation from
T5-6 and below. A note from R.M.’s record notes that the last time he was seen walking was on
Monday, May 16, 2016. See Pet’r Ex. 2 at 145 (“Upon further interview, I learned the last time
the mother had actually seen the patient walking was approximately 6:30 pm yesterday evening.
The mother denies any trauma and denies any evidence of unsteady gait or ataxia prior to 6:30
pm.”).
R.M. was admitted to inpatient rehabilitation center from May 26, 2016 through June 3,
2016. Pet’r Ex. 4 at 41-53. On September 1, 2016, R.M. had a follow-up appointment at the
Oregon Health and Science University Neurology Clinic. Pet’r Ex. 2 at 257. R.M. had
undergone plasmapheresis for three days, that “may have improved his sensory level.” Id. The
impression remained transverse myelitis. Id. at 259.
b. Ms. Brenlee McBane’s Affidavit
Petitioner filed an affidavit from Ms. Brenlee McBane, R.M.’s mother to describe the
events after R.M. received the vaccines at issue. Pet’r Ex. 15. She stated that she took R.M. to
the Rose City Urgent Care and Family Practice on March 9, 2016, where he received the
ProQuad vaccine in his right arm and the Kinrix vaccine in his left arm. Id. ¶ 3. R.M. fell asleep
in the car and woke up from his nap with a fever of 103 degrees. Id. at ¶ 4. Ms. McBane called
the doctor and he indicated that it was normal for a fever to occur after the vaccination, but if it
got worse to return to the office. Id.
According to Mrs. McBane, R.M. had a runny nose, cough, and breathing problems, and
threw up in the “following days.” Id. at ¶ 5. R.M. had a fever that would “come and go.” Id.
R.M.’s symptoms began to go away three weeks later, although Mrs. McBane stated that R.M.
“was not able to speak very well,” and that she and her husband were having a hard time
understanding what he was saying. Id. at ¶ 6.
In May, the family took a trip to Detroit Lake for a fishing derby. Id. at ¶ 7. Throughout
the trip, R.M. did not want to keep his shoes on. One day, we went to the lake and there were
rocks there. R.M. began walking on the rocks. He did not seem to be in any discomfort or pain
as he walked across them. Pet’r Ex. 15 at ¶ 7. She stated, “The following day, we went to 7/11.
Normally, when we went to 7/11, R.M. would run up the steps as quickly as he could. This time
he did not even want to walk. I had to carry him all the way up the stairs and around in the
store.” Id. ¶ 8.
Mrs. McBane stated, “That night, we were at home and R.M. was laying on his back in
bed watching a video. I took the video from him and he could not get up to chase me to try to
4

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 5 of 11
get the video back. He began to scream and cry because his legs began to hurt him. He seemed
to be losing sensation in his legs. It was then I realized that he may be paralyzed. Anytime that
he would try to walk he would continuously scream and cry.” Id. at ¶ 9.
c. Petitioner’s expert reports
Dr.Martinez-Arizala wrote that common causes of transverse myelitis, such as a vitamin
B12 deficiency, rheumatological disorders, neoplasms, Lyme disease, and viral infections, were
excluded with comprehensive laboratory tests and neuroimaging studies. Id. at 6. He stated that
“In R.M.’s case, [the] transverse myelitis was caused by his vaccination,’ and that “Systemic
infections or immunizations precede many cases of transverse myelitis. Vaccines are a well-
recognized trigger factor for transverse myelitis, and this has been consistently reported in the
literature.” Id. Dr. Martinez-Arizala proposed a theory of molecular mimicry and stated that
“components of the vaccine possess sequence similarities between it and specific human proteins
that results in the cross-reactivity of autoreactive T or B cells. This immune cross reactivity,
causes a reaction of the immune system against the pathogenic antigens that may harm the
similar human proteins, essentially causing autoimmune disease.” Id. at 8.
He noted that “multiple cases of post-vaccination TM have been reported in the
literature.” Id. Dr. Martinez-Arizala, referencing Agmon-Levin et al., wrote that “[thirty-seven]
cases of transverse myelitis occurred after vaccinations, which included six cases associated with
the MMR vaccine and four associated with the DPT or DT vaccines. In most of these cases, the
temporal association was between several days and three months, although a longer time frame
was also suggested.” Id.; see also Pet’r Ex. 26.3 He noted that the article by Chandra et al.
reported a case of transverse myelitis where symptoms started ten days after vaccinations for
MMR and influenza. Id. Dr. Martinez-Arizala wrote that R.M.’s symptoms began “seven weeks
after the vaccinations,” that this onset was “quite consistent with the literature as noted above.”
Id. at 7.
In response to the Rule 5 Order and Order to Show Cause, where I noted that the onset of
R.M.’s symptoms appeared to be closer to 67 days post-vaccination, Dr. Martinez-Arizala wrote
that “the time interval of 67 days from vaccination to the onset of symptoms is longer than
ordinary, but it is not unusual.” Pet’r Ex. 43 at 1. He again cited to the Agmon-Levin study and
wrote that the authors found “several cases with equally long, or longer-time intervals.” Id. He
then referenced a case report by Bir et al., where the onset of transverse myelitis occurred two
months after a 25-year-old man received a rabies vaccination. Id.; Pet’r Ex. 45 at 1.4 He also
referenced Karaali-Savrun et al. and Shaw et al., two articles that described case reports of
transverse myelitis after administration of the hepatitis B vaccine, where timing of onset of
3 N. Agmon-Levin et al., Transverse Myelitis and Vaccines: A multi-analysis, 18 Lupus 1198-1204 (2009). [Pet’r
Ex. 26].
4 Bir, Levent Sinan, et al., Acute Transverse Myelitis at the Conus Medullaris Level After Rabies Vaccination in a
Patient with Behcet’s Disease, 30 J. Spinal Cord Med. 294-96 (2007). [Pet’r Ex. 45].
5

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 6 of 11
transverse myelitis symptoms ranged from six weeks to sixteen weeks post-vaccination. See
Pet’r Exs. 465 & 47.6
d. Respondent’s expert report
Respondent submitted an expert report from Dr. Timothy Lotze, a pediatric neurologist.
Resp. Ex. A. Dr. Lotze agreed that R.M. had transverse myelitis. Id. at 7. He opined that “there
is no relationship between R.M.’s diagnosis of acute transverse myelitis and the vaccinations
given 9 weeks and 6 days before his first symptom.” Id.
Dr. Lotze wrote that “he agreed with Dr. Martinez-Arizala that R.M. first developed
neurological symptoms through the evening of 5/16/2016 into 5/17/2016, but I disagree that this
was 7 weeks from the time of his vaccinations on March 9, 2016. The difference in time
between the dates is 9 weeks and 6 days, which is well outside the window to consider any
relationship between the vaccines and his disease.” Id. Dr. Lotze noted that the case reports
cited by the Agmon-Levin paper, such as the case reported by Label and Batts, appeared to have
discrepancies between the timeline between vaccination and onset of transverse myelitis
symptoms. Id. at 5. He asserted that the case report from the Label and Batts article, which
described the development of transverse myelitis after a man received the rabies vaccine
demonstrated a seven-day timeline between the final vaccination and the onset of transverse
myelitis symptoms. Id. The Label and Batts paper wrote that a 50-year old man received a
rabies vaccine on October 10th, after being bitten by a racoon. Resp. Ex. A, Tab 3.7 On the
fourth day of the treatment, the man began to develop fatigue, lethargy, and “strange sensations”
in his head. Id. Two-days prior to coming into the emergency department on October 22nd, the
patient began to experience neck stiffness, numbness and weakness in his lower extremities. Id.
He was diagnosed with transverse myelitis and treated with steroids. Id. Dr. Lotze stated that
the case report indicates a seven-day onset between the vaccinations and symptoms of transverse
myelitis. Resp. Ex. A at 5. Dr. Lotze indicated that first symptoms of transverse myelitis were
numbness, weakness and neck stiffness, which began on October 20th, seven days after the
administration of the last vaccine, while Agmon-Levin appears to consider the fatigue,
lethargy and “strange sensations” as the first symptoms of onset, which would put
them at two-days post- vaccination.
Dr. Lotze also wrote that the Institute of Medicine (“IOM”) performed a comprehensive
review of the medical literature literature of vaccine-related transverse myelitis and “reached the
conclusion that the epidemiologic and mechanistic evidence is insufficient or absent to find an
association between [Dtap and MMR] vaccines and transverse myelitis.” Id. at 6; see also Resp.
Ex. A, Tab 7. He opined that any incidents of transverse myelitis and vaccinations “is
5 F. Karaali-Savrun et al., Hepatitis B vaccine-related myelitis? 8 European J of Neurol. 711-15 (2001). [Pet’r Ex.
46].
6 F.E. Shaw et al., Postmarketing Surveillance for the Neurologic Adverse Events Reported After Hepatitis B
Vaccination, 127 American J. of Epidemiology 337-352. [Pet’r Ex. 47].
7 L. Label, et al., Transverse Myelitis Caused by Duck Embryo Rabies Vaccine, 39 Arch. Neurol. 426-30 (1982).
[Resp. Ex. A, Tab 3].
6

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 7 of 11
coincidental and does not equate to causation.” Id. Dr. Lotze concluded his report by reiterating
his opinion that the vaccinations were the not the cause of R.M.’s transverse myelitis.
III. Standard for Adjudication
The Vaccine Act was established to compensate vaccine-related injuries and deaths.
§10(a). To receive compensation through the Program, petitioner must prove either (1) that he
suffered a “Table Injury”—i.e. an injury listed on the Vaccine Injury Table—corresponding to a
vaccine he received, or (2) that he suffered an injury that was actually caused by a vaccination.
See §§11(c)(1), 13(a)(1)(A); Capizzano v. Sec’y of Health & Human Servs., 440 F.3d 1317, 1325
(Fed. Cir. 2006).
Because petitioner does not allege that R.M. suffered a Table Injury, he must prove a
vaccine that R.M. received actually caused his injury. To do so, petitioner must establish, by
preponderant evidence: (1) a medical theory causually 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 proximate temporal relationship between vaccination and injury.”
Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
Petitioners 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, 1378-49 (Fed. Cir. 2009).
To satisfy this prong, a 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). 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 (“medical records and medical
opinion testimony are favored in vaccine cases, and treating physicians are likely to be in the
best position to determine whether a ‘logical sequence of cause-and-effect show[s] that the
vaccination was the reason for the injury’ ”) (quoting Althen, 418 F.3d at 1280). The third
Althen prong requires establishing a “proximate temporal relationship” between vaccination and
the injury alleged. Althen, 418 F.3d at 1281. A petitioner must offer “preponderant proof that
the onset of symptoms occurred within a timeframe which, given the medical understanding of
the disorders etiology, it is medically acceptable to infer causation.” de Bazan v. Sec’y of Health
& Human Servs., 539 F.3d 1347, 1352 (Fed. Cir. 2008). The explanation for what is medically
acceptable timeframe must also coincide with the theory of how the relevant vaccine can cause
the injury (Althen prong one requirement). Id. at 1352. Evidence demonstrating petitioner’s
injury occurred within a medically acceptable time frame bolsters a link between the injury
alleged and the vaccination at issue under the ‘but-for’ prong of the causation analysis. Pafford
v. Sec’y of Health & Human Servs., 451 F.3d 1352, 1358 (Fed. Cir. 2006).
Petitioner cannot establish entitlement to compensation based solely on assertions.
Rather a vaccine claim must be supported by either medical records or by the opinion of a
medical doctor. § 13(a)(1). The special master is required to consider “all relevant medical and
scientific evidence contained in the record,” including “any diagnosis, conclusion, medical
judgment, or autopsy or coroner’s report which is contained in the record regarding the nature,
7

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 8 of 11
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.” §13(b)(1)(A). Medical records created contemporaneously with
the events they describe are generally trustworthy because they “contain information supplied to
or by health professionals to facilitate diagnosis and treatment of medical conditions,” where
“accuracy has an extra premium.” Kirby v. Sec’y of Health & Human Servs., 997 F.3d 1378
(fed. Cir. 2021) citing Cucuras, 993 F.2d at 1528. To overcome the presumptive accuracy of
medical records, a petitioner may present testimony which is “consistent, clear, cogent, and
compelling.” Sanchez v. Sec’y of Health & Human Servs., No.11-685V, 2013 WL 1880825, at
*3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec’y of Health & Human Servs., No.
90-2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)), mot. for rev. denied,
142 Fed. Cl. 247 (2019), vacated on other grounds & remanded, 809 F.App’x 843 (Fed. Cir.
2020).
IV. Analysis and Conclusion
The ultimate matter in this case is not the theory of vaccine causation proposed by
petitioner’s expert, Dr. Martinez-Arizala, but the theory proposed in connection with the onset of
R.M.’s transverse myelitis. The third prong of Althen requires establishing a “proximate
temporal relationship” between the vaccination and the injury alleged. ALthen, 418 F.3d at 1281.
A petitioner must offer “preponderant proof that the onset of symptoms occurred within a
timeframe, which, given the medical understanding of the disorder’s etiology, it is medically
acceptable to infer causation. De Bazan v. Sec’y of Health & Human Servs., 539 F.3d 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. Id.; see also Shapiro v.
Sec’y of Health & Human Servs., 101 Fed. Cl. 532, 542 (2011), recons. denied 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 denied (Fed. Cl. Dec. 3, 2013), aff’d, 773 F.3d 1239 (Fed. Cir. 2014).
Dr. Martinez-Arizala opined that the vaccine R.M. received on March 9, 2016 could
result in transverse myelitis through a theory of molecular mimicry. Pet’r Ex. 16 at 6. He noted
that medical literature, including the articles by Rojas and Agmon-Levin endorse a theory of
molecular mimicry as a mechanism for inducing an autoimmune disease, such as transverse
myelitis. See Pet’r Exs. 248 and 44. The theory of molecular mimicry has been accepted as a
causal mechanism for inducing transverse myelitis and other central nervous system diseases in
this program and I have accepted such a theory in other cases. See e.g. Le v. Sec’y of Health &
Human Servs., No. 16-1078V, 2023 WL 3049203 (Spec. Mstr. Fed. Cl. Mar. 30, 2023) (finding
that the Tdap vaccine can cause transverse myelitis through the mechanism of molecular
mimicry); Roberts v. Sec’y of Health & Human Servs., No. 90-427V, 2013 WL 5314698, at *6-7
(Fed. Cl. Spec. Mstr. Aug. 29, 2013) (finding the petitioner entitled to compensation in a
Tdap/TM case with the theory of molecular mimicry); Introini v. Sec’y of Health & Human
Servs., No. 20-176V, 2022 WL 16915818 (Fed. Cl. Spec. Mstr. Oct. 19, 2022) (finding that the
Tdap vaccine can cause TM via molecular mimicry); White v. Sec’y of Health & Human Servs.,
8 M. Rojas et al., Molecular mimicry and autoimmunity, 95 J. of Autoimmunity 100-23. [Pet’r Ex. 24].
8

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 9 of 11
No. 15-1512V, 2019 WL 7563239 (Fed. Cl. Spec. Mstr. Dec. 19, 2019) (finding that the HPV
vaccine can cause transverse myelitis through a theory of molecular mimicry). Thus, I am
willing to accept petitioner’s theory of molecular mimicry as a causal mechanism for transverse
myelitis.
Dr. Martinez-Arizala opined that a 67-or-68-day timeframe after vaccination is a
medically acceptable timeframe for transverse myelitis symptoms to begin to infer causation.
Pet’r Ex. 16 at 7; Pet’r Ex. 43. The case reports he references in his second report, where onset
of transverse myelitis occurred six to seven weeks post-vaccination, are not persuasive. In
particular because these case reports are referencing the onset of transverse myelitis after
administration of the hepatitis B vaccine, which is not at issue in this matter. See Pet’r Ex. 46
(describing four cases of transverse myelitis after administration of the hepatitis B vaccine). The
Agmon-Levin article, which includes a more comprehensive review of transverse myelitis
following vaccination, notes that four cases of transverse myelitis were identified following
receipt of the measles-mumps-rubella or rubella vaccines, but onset began at the earliest four
days post-vaccination and the latest, 21 days post-vaccination. See Pet’r Ex. 44. Of the DTP,
DT or pertussis vaccines reported Agmon-Levin, the intervals between vaccination and onset of
symptoms was between three and seventeen days. Id. In another case report referenced by Dr.
Martinez-Arizala, onset of neurological symptoms of transverse myelitis occurred ten days after
administration of the influenza and MMR vaccines. Pet’r Ex. 29.9 Two additional case reports
were listed in the Journal of Paediatrics & Child Health Letter to the Editor, describing the onset
of transverse myelitis in a 14-year-old girl eight days after receiving the diphtheria-tetanus, oral
polio, and rubella vaccines and a young boy developing transverse myelitis twenty-three days
after receiving the diphtheria-tetanus toxoid and oral polio vaccines. Pet’r Ex. 30 at 1.10 The
medical literature filed in this case, puts the onset of transverse myelitis much closer in time to
vaccination, compared to the interval between R.M.s vaccines and his transverse myelitis.
R.M. received the diphtheria-tetanus-acellular-pertussis and inactivated polio vaccine and
the measles, mumps, rubella, and varicella vaccine on March 9, 2016. There are no medical
records between the time of vaccination and May 16, 2016, when he initially presented to the
emergency department of St. Vincent Medical Center for an evaluation of leg pain and being
unable to walk. Pet’r Ex. 3 at 2. The medical record from Oregon Health & Science University
pediatric neurology consult provides more detail as to when R.M. was last seen walking, which
was earlier in the day on May 16, 2016. It explains:
[R.M.] is a 4-year 3 month previously healthy male with acute onset lower extremity
paraplegia. Was in his usual state of health until Monday evening. Mom walked with
[R.M.] to get a slurpee at 7-11 around 6:30 pm. He was walking fine. Went home and he
was laying on mom’s bed playing with her phone. She took her phone away to answer
the phone and he started whining and slid off the bed….Mom picked him up and put him
back on the bed…She then left the room and then when went back into the room he was
on the floor again. She did not see if he fell or if he tried to walk and fell. Seemed to be
9 A.Chandra et al., Vaccine Induced Acute Transverse Myelitis: A Case Report, 13 Nepal J. of Neuroscience 89-91
(2016). [Pet’r Ex. 29].
10 Letter to the Editor, 41 J. Paediatr. Child Health 460 (2005). [Pet’r Ex. 30].
9

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 10 of 11
clutching at his lower abdomen/suprapubic area. When he was crying for 30 minutes,
mom took him to ED at St. Vincent. While he was there he complained of abdominal
pain. Was discharged. However, worsening pain so returned to DCH ED. Was
evaluated for abdominal pain, but when [R.M.]...stood up to be discharged noted to have
paralysis.
Pet’r Ex. 2 at 26. This record is also consistent with what the emergency department physician,
Dr. Cloutier wrote when R.M. was taken back into the emergency department after throwing up
again in the car. He wrote, “Patient refused to stand and appeared to have flaccid paralysis
below the hips. Upon further interview, I learned the last time the mother had actually seen the
patient walking was approximately 6:30 yesterday evening.” Id. at 145.
As discussed in the Order to Show Cause, Ms. McBane’s affidavit appears to somewhat
contradict the medical record, indicating that R.M. did not walk to 7-11, but instead she had to
carry him. Pet’r Ex. 15 at ¶¶ 7-8. But more significantly, Ms. McBane’s affidavit does not
contain a date more specific than “May” for the fishing trip or the visit to 7-11, but the medical
records appear clear that the latter occurred on May 16th, prior to taking her taking R.M. to the
emergency room. She describes this as the day following the fishing trip. Id. at ¶ 8. Further, her
affidavit was created in 2022, when the medical records were contemporaneously created for the
treatment of R.M. when he presented with rather dramatic symptoms. Given that the medical
records appear to be internally consistent and were created contemporaneously to treat R.M.
when he presented with dramatic symptoms, these records are afforded substantial weight.
Special masters have found that a petitioner was entitled to causation where onset
occurred up to two months, or 56 days following the flu vaccination. Spayde v. Sec’y of Health
& Human Servs., No. 16-1499V, 2021 WL 686682 (Fed. Cl. Spec. Mstr. Jan. 27, 2021)
(accepting a 56-day onset for GBS following flu vaccination) (citing to Barone v. Sec’y of Health
& Human Servs., No. 11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr. Nov. 12, 2014)
(finding a six-week or 42-day interval from vaccination to onset of petitioner’s GBS). However,
these are cases involving the influenza vaccine and Guillain-Barré syndrome, and not the
occurrence of transverse myelitis following a Tdap vaccine. Further, other compensated cases
where petitioners suffered from transverse myelitis following the Tdap vaccination had onset of
symptoms much closer in time to the administration of the vaccine. See e.g. Roberts v. Sec’y of
Health & Human Servs., No. 09-427V, 2013 WL 5314698 (onset of symptoms began four weeks
after Tdap vaccination); Helman v. Sec’y of Health & Human Servs., No. 10-813V, 2012 WL
1607142, at *3 (Fed. Cl. Spec. Mstr. Apr. 5, 2012) (finding onset of symptoms occurring three
weeks after Tdap vaccination); Raymo v. Sec’y of Health & Human Servs., NO. 11-0654V, 2014
WL 1092274, at *19 (Fed. Cl. Spec. Mstr. Feb. 24, 2014) (finding a three to four-day onset of
transverse myelitis following administration of Tdap vaccine to medically appropriate temporal
relationship).
As I indicated in the Rule 5 Order in this matter and in Archer, another late onset
transverse myelitis case, I do not consider there to be hard line for establishing a medically
appropriate timeframe, especially if the proposed timeframe is supported by medical literature
and coincides with a sound and reliable mechanism for vaccine causation. See Archer v. Sec’y of
Health & Human Servs., 2021 WL 2666692, at *24 (Fed. Cl. Spec. Mstr. May 27, 2021).
10

Case 1:19-vv-00350-UNJ Document 63 Filed 05/10/24 Page 11 of 11
However, in this matter, the medical literature Dr. Martinez-Arizala referenced to support an
onset of 67 days post-vaccination refers to a vaccine that R.M. did not receive on March 9, 2016,
and the range for symptom onset post-vaccinations regarding the vaccines that R.M. did receive
was much closer in time that in this matter. Accordingly, petitioner did not provide preponderant
evidence to satisfy Althen prong three.
V. Conclusion
It is not without difficulty that I have come to the conclusion discussed above, as R.M.
clearly has a permanent, disabling condition. Unfortunately, the evidence that was submitted in
this matter, including the medical literature, the medical records, and the expert reports, is
insufficient to demonstrate that the vaccines R.M. received on March 9, 2016, played a causal
role in him developing transverse myelitis 67 days post-vaccination.
Accordingly, petitioner’s claim must be and is hereby DISMISSED. In the absence of a
motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court is directed to enter
judgment forthwith.11
IT IS SO ORDERED.
s/ Thomas L. Gowen
Thomas L. Gowen
Special Master
11 Entry of judgment is expedited by each party’s filing notice renouncing the right to seek review. Vaccine Rule
11(a).
11