In the United States Court of Federal Claims
No. 18-1065V
(E-Filed: October 18, 2021) 1
)
RAFAEL FRANCISCO OJEDA )
COLON, )
)
Influenza Vaccine; National Vaccine
Petitioner, )
Injury Compensation Program, 42
)
U.S.C. §§ 300aa-10, et seq.; Six-month
v. )
Severity Requirement; 42 U.S.C.
)
§ 300aa-11(c)(1)(D); Review of
SECRETARY OF HEALTH AND )
Special Master’s Decision.
HUMAN SERVICES, )
)
Respondent. )
)
Roberto E. Ruiz-Comas, San Juan, PR, for petitioner.
Althea Walker Davis, Senior Trial Counsel, with whom were Brian M. Boynton, Acting
Assistant Attorney General, C. Salvatore d’Alessio, Acting Director, Heather L.
Pearlman, Deputy Director, Alexis B. Babcock, Assistant Director, Torts Branch, Civil
Division, United States Department of Justice, Washington, DC, for respondent.
OPINION
CAMPBELL-SMITH, Judge.
Petitioner filed the petition in this case on July 20, 2018. See ECF No. 1. The
special master issued his initial entitlement decision on June 3, 2021, see ECF No. 60,
and denied petitioner’s motion for reconsideration on June 30, 2021, see ECF No. 63. On
July 1, 2021, petitioner filed a motion for review with this court, see ECF No. 64, and
1
This opinion was filed under seal on September 22, 2021, in accordance with Rule 18(b)
of the Vaccine Rules, Appendix B to the Rules of the United States Court of Federal Claims.
See ECF No. 68. Pursuant to ¶ 4 of the ordering language, the parties were to propose redactions
of the information contained therein on or before October 6, 2021. No proposed redactions were
submitted to the court. Therefore, this public version of the opinion is identical to the sealed
version with the exception of the date and content of this footnote.
respondent filed a response, on July 30, 2021, see ECF No. 67. Petitioner did not seek to
file a reply.
The motion is now fully briefed and ripe for ruling. The court has considered all
of the arguments presented by the parties and addresses the issues that are pertinent to the
court’s ruling in this opinion. For the following reasons, petitioner’s motion for review is
DENIED, and the special master’s June 3, 2021 entitlement decision is SUSTAINED.
I. Background 2
A. Medical Records
On October 17, 2013, petitioner received an influenza vaccination. See ECF No.
60 at 3. Petitioner was seventy years old at the time. See id. On or about October 23,
2013, petitioner developed numbness in his left leg, and began dragging his left foot. See
id. On October 29, 2013, petitioner saw Dr. Edgardo Colon Zavala, and reported
symptoms of difficulty walking and mild numbness and tingling in his left foot. See id.
Petitioner also reported two days of diarrhea “after eating food in Columbia” on vacation.
Id. Dr. Zavala’s diagnosis was “acute infective polyneuritis,” and he recommended that
petitioner undergo “further evaluation for possible vaccine-induced [Guillain-Barré
Syndrome (GBS)].” Id. at 3-4.
Petitioner was admitted to the hospital the same day for a “chief complaint of
bilateral foot drop with numbness.” Id. at 4. He reported difficulty walking, tingling in
the soles of his feet, difficulty lifting his feet, and “no diarrhea prior to symptoms, only
[two] days after symptoms.” Id. (internal quotation marks and citation omitted). On
October 31, 2013, petitioner was diagnosed with GBS and received intravenous
immunoglobulin therapy to “prevent progression.” Id.
On November 4, 2013, petitioner completed the intravenous treatment and a
doctor’s note indicated that petitioner had no “new def[icits].” Id. (internal quotation
marks and citation omitted) (alteration in original). The next day, petitioner’s medical
records indicate that his condition had not further deteriorated, but that he was suffering
from constipation. See id. On November 6, 2013, petitioner was discharged from the
hospital “with diagnoses of GBS, polyradiculopathy, and diabetes mellitus.” Id.
2
In describing the background of petitioner’s claim, the court refers primarily to the
special master’s findings of fact. See ECF No. 60 at 3-7. Petitioner’s assignments of error do
not contest the facts as stated by the special master, but rather challenge the legal conclusions
drawn from those facts. See generally, ECF No. 64.
2
On November 7, 2013, petitioner saw Dr. Priscilla Mieses Llavat, who noted that
he had a decreased range of motion, reduced strength, and decreased sensation in his
distal lower extremities. See id. Dr. Llavat directed petitioner to attend physical therapy
for GBS and left foot drop. See id.
On November 19, 2013, petitioner saw his primary care doctor, Dr. Gabriel
Hernandez Denton, who noted both petitioner’s GBS diagnosis and his constipation with
an “episode of fecal compaction.” Id.
Petitioner saw Dr. Llavat on a number of occasions throughout the next several
months, including November 22, 2013, December 24, 2013, January 27, 2014, and
February 11, 2014. See id. at 5. At the February 11, 2014 appointment, Dr. Llavat noted
that petitioner had GBS and left foot drop, but stated that his condition was improved and
that his numbness had “abated.” Id. She recommended that he engage in exercises at
home. See id.
Petitioner saw Dr. Denton on April 24, 2014, and May 1, 2014, due to “changes in
his [b]owel habits.” Id. (internal quotation marks and citation omitted) (alteration in
original). On May 9, 2014, petitioner had a colonoscopy which revealed a colon polyp
and hemorrhoids. See id. Petitioner saw Dr. Denton again on July 22, 2014, at which
time Dr. Denton diagnosed petitioner with chikungunya, a mosquito-borne virus. See id.
On September 2, 2014, petitioner saw Dr. Llavat and reported bilateral hand pain
“that started [seven] weeks ago with viral infection. No numbness.” Id. (internal
quotation marks and citation omitted) (alteration in original). Despite noting problems
with range of motion and pain, “[t]here was no mention of sequelae of GBS at this visit.”
Id.
On October 20, 2014, petitioner saw Dr. Denton who noted that petitioner was
“‘S/P [status post]’ GBS and chikungunya.” Id. Petitioner saw Dr. Denton again on
December 16, 2014, for routine lab work. See id. The only specific result noted was that
his stool was negative for blood. See id.
One of petitioner’s doctors noted, on January 12, 2015, that petitioner fell and hurt
his right wrist and right knee, but did not mention any sequelae of GBS. See id.
On July 13, 2015, Dr. Denton visited petitioner at his home and noted that
petitioner had “multiple pelvic fractures due to a fall.” Id. at 6. On August 5, 2015, Dr.
Llavat examined petitioner at his home and noted that petitioner had fallen from a horse
in June 2015 and suffered multiple fractures to his pelvic and hip area. See id.
3
More than two years later, on December 18, 2017, Dr. Denton noted that petitioner
had both type two diabetes and hypercholesterinemia, but mentioned no additional issues.
See id.
In addition to the medical records previously noted, Dr. Llavat drafted a letter
explaining that petitioner participated in physical therapy ten times from November 2013
through June 2017. See id. Dr. Llavat, however, did not provide any detailed notes
about the visits or the reasons for the treatment. See id.
Finally, on October 1, 2019, petitioner saw Dr. Jose Carlo and requested his
“opinion and recommendations regarding his sequelae of the GBS.” 3 Id. (internal
quotation marks and citation omitted). Dr. Carlo found: (1) “droop in the left nasolabial
fold and mouth, which seems to date from GBS. [Petitioner] cannot whistle since his
GBS;” (2) petitioner “[c]annot walk tandem;” and (3) reduced sensation to cold,
vibration, and pin, “below the calves, bilaterally, but more pronounced in the left distal
leg.” Id. (internal quotation marks and citation omitted) (alteration in original).
According to Dr. Carlo, “the sequela of [p]etitioner’s GBS included ‘distal leg weakness,
facial weakness . . and distal, asymmetrical, sensory deficit . . . in the legs.’” Id. (citation
omitted). He further assessed that the conditions were likely permanent. See id. at 7.
B. Affidavits
Petitioner submitted an affidavit in which he claims that he “spent almost a year
recovering from a severe foot drop for which [he] initially had to use crutches and then
later on move[d] to ambulating with a cane.” Id. at 6 (internal quotation marks and
citation omitted). He also stated that he suffered from constipation “for about six months
after the vaccination,” and that he “continued to suffer from poor balance and falls.” Id.
(internal quotation marks and citations omitted).
Affidavits were also submitted by petitioner’s wife, Ms. Ada Diez de Ojeda, and
two acquaintances, Mr. Vincente E. Rios and Mr. Eugenio Perez Matos. See id. at 5-6.
Ms. Diez de Ojeda states that her husband suffered from occasional constipation
beginning in November 2013 through February 29, 2020. See id. at 6. Both Mr. Rios
and Mr. Perez Matos attested that they saw petitioner’s “‘left leg [give away] while
walking’ on December 30, 2014.” Id. at 5 (citation omitted) (alteration in original).
3
The special master refers to Dr. Carlo as Dr. Carlos throughout his entitlement decision.
See generally, ECF No. 60. It appears from the record that Dr. Carlo is correct. See ECF No.
61-2 (letter written by Dr. Jose R. Carlo, attaching his curriculum vitae).
4
C. Special Master’s Decisions
In the entitlement decision, the special master explained that petitioner was
required to “demonstrate that his injuries continued through at least mid-to-late April
2014.” Id. at 7. To support this conclusion, the special master cited to 42 U.S.C.
§ 300aa-11 of the National Vaccine Compensation Act, which states, in relevant part, that
a petition must include documentation “demonstrating that the person who suffered such
injury . . . suffered the residual effects or complications of such illness, disability, injury,
or condition for more than 6 months after the administration of the vaccine.” 42 U.S.C. §
300aa-11(c)(1)(D)(i).
After reviewing the evidence submitted by petitioner, the special master concluded
that petitioner had not met this burden. See ECF No. 60 at 7. He explained that “the
medical records reflect that [p]etitioner was last assessed with GBS sequelae on February
11, 2014—approximately four months from onset. And there are no records thereafter
that document specific treatment or care associated with the GBS that [p]etitioner
unquestionably experienced in the fall of 2013.” Id. On this basis, the special master
dismissed the petition. See id. at 10.
Petitioner moved for reconsideration of the special master’s decision. See ECF
No. 62. Petitioner attached new medical documentation to the motion, and also argued
that an intervening change in controlling law militated in favor of reconsideration, citing
Kirby v. Secretary of Health and Human Services, 997 F.3d 1378 (Fed. Cir. 2021). See
id. at 2. The special master denied the motion, explaining that the medical
documentation was unpersuasive, see ECF No. 63 at 5, and that the entitlement decision
“follows the contours of Kirby even if it does not explicitly invoke it,” id. at 4.
Petitioner now seeks review of the special master’s determination that petitioner
has not satisfied the six-month severity requirement. See ECF No. 64.
II. Legal Standards
This court has jurisdiction to review the decision of a special master in a Vaccine
Act case. See 42 U.S.C. § 300aa-12(e)(2). “Under the Vaccine Act, the Court of Federal
Claims reviews the decision of the special master to determine if it is ‘arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law[.]’” de Bazan
v. Sec’y of Health & Hum. Servs., 539 F.3d 1347, 1350 (Fed. Cir. 2008) (quoting 42
U.S.C. § 300aa-12(e)(2)(B) and citing Althen v. Sec’y of Health & Hum. Servs., 418
F.3d 1274, 1277 (Fed. Cir. 2005)).
This court uses three distinct standards of review in Vaccine Act cases, depending
upon which aspect of a special master’s judgment is under scrutiny.
5
These standards vary in application as well as degree of deference. Each
standard applies to a different aspect of the judgment. Fact findings are
reviewed . . . under the arbitrary and capricious standard; legal questions
under the “not in accordance with law” standard; and discretionary rulings
under the abuse of discretion standard.
Munn v. Sec’y of Dep’t of Health & Hum. Servs., 970 F.2d 863, 870 n.10 (Fed. Cir.
1992).
As the United States Court of Appeals for the Federal Circuit has held, when
reviewing a special master’s decision, this court does not “reweigh the factual evidence,
assess whether the special master correctly evaluated the evidence, or examine the
probative value of the evidence or the credibility of the witnesses—these are all matters
within the purview of the fact finder.” Porter v. Sec’y of Health & Hum. Servs., 663 F.3d
1242, 1249 (Fed. Cir. 2011). “Rather, as long as a special master’s finding of fact is
‘based on evidence in the record that [is] not wholly implausible, we are compelled to
uphold that finding as not being arbitrary or capricious.’” Id. (quoting Cedillo v. Sec’y of
Health & Hum. Servs., 617 F.3d 1328, 1338 (Fed. Cir. 2010)). Under this standard
“reversible error is ‘extremely difficult to demonstrate’ if the special master ‘has
considered the relevant evidence of record, drawn plausible inferences and articulated a
rational basis for the decision.’” Lampe v. Sec’y of Health & Hum. Servs., 219 F.3d
1357, 1360 (Fed. Cir. 2000) (quoting Hines v. Sec’y of Health & Hum. Servs., 940 F.2d
1518, 1528 (Fed. Cir. 1991)).
Petitioner bears the burden of proving his case by a preponderance of the
evidence, including that he “suffered the residual effects or complications of such illness,
disability, injury, or condition for more than 6 months after the administration of the
vaccine.” 42 U.S.C. § 300aa-11(c)(1)(D)(i); see Song v. Sec’y of Dep’t of Health &
Human Servs., 31 Fed. Cl. 61, 65-66 (1994), aff’d, 41 F.3d 1520 (Fed. Cir. 2014) (noting
that a petitioner must demonstrate the six-month severity requirement by a preponderance
of the evidence).
III. Analysis
Petitioner assigns three errors to the special master’s entitlement decision. First,
he argues that the special master “engaged in arbitrary and capricious fact-finding in
evaluating whether the evidence showed that petitioner satisfied the Vaccine Act’s
severity requirement for a Table Injury.” ECF No. 64 at 2. Second, he argues that the
special master applied an “erroneous legal standard for silent medical records together
with non-conflicting affidavits.” Id. And finally, he argues that the special master
“applied an impermissibly high burden of proof for the ‘preponderance of the evidence’”
standard that governs whether the six-month severity requirement is met. Id. The court
will address each of petitioner’s concerns in turn.
6
A. The Special Master’s Fact-Finding Was Not Arbitrary or Capricious
According to petitioner, his medical records “together with the new medical
opinion letter . . . by Dr. Priscilla Mieses Llavat [submitted with his motion for
reconsideration], fulfilled his burden of proof that it is medically reasonable and more
probable than not that [p]etitioner’s GBS sequelae could not ha[ve] been resolved by the
beginning of May 2014 at a minimum, fulfilling the six-month severity requirement.” 4
Id. at 5. Petitioner also argues that the special master failed to take into consideration that
he had not been released from physical therapy at the time of his February 11, 2014
appointment. See id. at 6. The special master’s failure to do so, petitioner contends, was
arbitrary and capricious. See id.
The court is unconvinced by petitioner’s argument for two reasons. First, in his
decision denying petitioner’s motion for reconsideration, the special master cogently
explained why he found Dr. Llavat’s new opinion letter to be unpersuasive. See ECF No.
63 at 5. He noted that Dr. Llavat’s letter lacked precision, and that petitioner offered no
explanation as to why the letter and accompanying chart now offered to clarify earlier-
submitted records “could not have been added to the record long prior to” the entitlement
decision. Id.
In addition, the special master’s decision documented petitioner’s medical records
in detail, see ECF No. 60 at 3-7, including the February 11, 2014 note in which Dr.
Llavat “assessed [petitioner] with GBS and left foot drop,” and recommended that
petitioner do exercises at home, id. at 5. The special master observed that “the medical
records reflect that [p]etitioner was last assessed with GBS sequelae on February 11,
2014—approximately four months from onset. And there are no records thereafter that
document specific treatment or care associated with the GBS that [p]etitioner
unquestionably experienced in the fall of 2013.” Id. at 7 (citation omitted).
The special master reviewed the evidence submitted by petitioner “in toto,” and
concluded that the medical “record establishes (a) no specific GBS treatment after
February 2014, (b) no mention of GBS sequelae thereafter either, but (c) ample evidence
for the three to four-year period after substantiating treatment for many other conditions
and illnesses, some of which might better explain [p]etitioner’s [gastro-intestinal]
distress.” Id. at 8. He further found that it was reasonable to conclude “that [p]etitioner
4
In this section of his motion for review, petitioner also quotes from the expert opinion
letter written by Dr. Jose Carlo that petitioner submitted with his motion for reconsideration. See
ECF No. 64 at 4. Petitioner’s substantive argument, however, omits any discussion of how that
letter should have been considered, instead addressing only Dr. Llavat’s letter. See id. at 5-6.
The court cannot construct petitioner’s argument on his behalf, and thus, does not address Dr.
Carlo’s letter in detail in this opinion.
7
would have sought treatment or intervention if he had continued to suffer sequelae for his
GBS, and/or that his treaters would have mentioned it—and the fact that the records are
silent on these matters has more evidentiary significance than [p]etitioner’s after-the-fact
assertions of ongoing symptoms.” Id.
Petitioner has not demonstrated, or even argued, that the special master
overlooked or discounted medical records that reference his continued physical therapy to
treat GBS sequelae. To the contrary, petitioner seems to suggest that the absence of a
record releasing him from treatment should be understood as evidence that such treatment
continued. See ECF No. 64 at 5. The court disagrees. Plaintiff bears the burden of
demonstrating by a preponderance of the evidence that he meets the six-month severity
requirement, see Song, 31 Fed. Cl. at 65-66, and the special master reasonably considered
the evidence timely submitted by petitioner in determining that he failed to do so.
B. The Special Master Did Not Apply an Erroneous Legal Standard
Petitioner argues that “a motion for review is also warranted as there has been an
intervening change in controlling law,” in reference to Kirby v. Secretary of Health and
Human Services, 997 F.3d 1378 (Fed. Cir. 2021). 5 Id. at 6. According to petitioner, the
special master should have, but did not, apply the holding from Kirby with regard to
circumstances in which medical records are silent as to a material issue. See id. at 7.
Specifically, in Kirby, the Federal Circuit made clear that no presumption exists “that
medical records are accurate and complete as to all the patient’s physical conditions.”
Kirby, 997 F.3d at 1382. Petitioner contends that the special master improperly credited
such a presumption in this case. See ECF No. 64 at 7.
Petitioner also raised this issue in his motion for reconsideration, see ECF No. 62
at 2, which gave the special master the opportunity to explain why the entitlement
decision is consistent with Kirby. He stated as follows:
My Decision was consistent with Kirby. In it, I noted that there were no
records after February 11, 2014, that documented specific treatment or care
associated with [p]etitioner’s previous GBS diagnosis. But I did not end my
analysis there. Rather, I also considered and weighed witness statements and
testimony, as well as other subsequent records offered to support ongoing
sequelae. In effect, my overall balancing of all evidence offered in the record
5
The court notes that Kirby v. Secretary of Health and Human Services, 997 F.3d 1378
(Fed. Cir. 2021), was decided on May 20, 2021, two weeks before the special master issued his
entitlement decision on June 3, 2021, see ECF No. 60. As such, the decision is not properly
considered to be an intervening one; rather, Kirby was binding precedent at the time the special
master rendered the entitlement decision.
8
resulted in my severity determination—it did not flow from my unexamined
preference for what the medical records say in the face of contrary
allegations. As such, Kirby cannot be said to compel a different outcome,
such that reconsideration in light of it is required.
ECF No. 63 at 4 (citations omitted). In the court’s view, this is a fair assessment of the
special master’s analysis.
The special master engaged in a detailed analysis of both the medical records and
the affidavits submitted by petitioner. See ECF No. 60 at 7-10. There is no indication
that the special master applied a presumption that because petitioner’s medical records
did not mention GBS after February 11, 2014, he could not meet the severity
requirement. Instead, the special master noted the important facts that, although
petitioner saw doctors following various falls that occurred after February 11, 2014, the
records from those visits did not mention GBS sequelae. See id. at 8 (noting medical
record indicating difficult walking following a fall from a horse); 9 (noting affidavits and
medical record indicating injuries to his right wrist and right knee from a fall).
Furthermore, the special master concluded his analysis by noting as follows:
I am aware that a variety of evidence can be used to satisfy issues like
severity, and I am reluctant to dismiss a case simply on this basis, especially
given the [Vaccine] Program’s emphasis on generosity in reaching
entitlement decisions. However, severity is a claim requirement, and cases
may legitimately be dismissed if the record does not preponderantly reveal
sufficient evidentiary support for this claim element. Here, I have conducted
a thorough record review in reaching my determination, and even giving
[p]etitioner’s witness statements some weight, I cannot find that severity is
met.
Id. at 10 (citations omitted).
Regardless of whether the court would have reached the same conclusion, it is
clear that the special master’s decision complies with the Federal Circuit’s decision in
Kirby because he considered the record as a whole, rather than presuming petitioner
could not meet the severity requirement based only on the medical records. See Porter,
663 F.3d at 1249 (stating that in reviewing a special master’s decision, this court does not
“reweigh the factual evidence, assess whether the special master correctly evaluated the
evidence, or examine the probative value of the evidence or the credibility of the
witnesses—these are all matters within the purview of the fact finder”).
9
C. The Special Master Properly Applied the Preponderance of the Evidence
Standard
Of petitioner’s three arguments, his argument that the special master applied an
“erroneous[ly] high burden of proof,” is the least persuasive. ECF No. 64 at 10. After
reciting the preponderance of the evidence standard and other required elements of a
successful claim, petitioner contends that the special master inappropriately applied a
heightened standard of proof in petitioner’s case. See id. at 9-10. Petitioner does not,
however, define what that higher burden was, or explain how it departed from the
preponderance standard. See id. at 9-11. Petitioner simply argues, without specifically
identifying the evidence to which he refers, that the special master was “arbitrarily and
capriciously unfair to [p]etitioner when weighing all the evidence by disregarding
medical opinion evidence on GBS musculoskeletal sequelae.” Id. at 11.
The court has thoroughly reviewed the special master’s entitlement decision, and
sees no indication that the special master employed an improperly heightened standard of
proof. The special master acknowledged the proper standard, see ECF No. 60 at 2-3,
recited the relevant facts at length, see id. at 3-7, carefully considered the record, see id.
at 7-10, and noted his hesitance to dismiss a case for failure to meet the severity
requirement, see id. at 10, but ultimately found that “[b]ased on the record as a whole,
[p]etitioner has failed to prove by preponderant evidence that his GBS or its residual
effects lasted for more than six months,” id.
Absent a more specific and meritorious argument from petitioner or an obvious
error in the special master’s application of the preponderance standard, the court will
sustain the decision.
IV. Conclusion
Accordingly, for the foregoing reasons:
(1) Petitioners’ motion for review, ECF No. 64, is DENIED;
(2) The decision of the special master, filed on June 3, 2021, ECF No. 60,
is SUSTAINED;
(3) The clerk’s office is directed to ENTER final judgment in accordance with
the special master’s June 3, 2021 decision; and
(4) On or before October 6, 2021, the parties shall separately FILE any
proposed redactions to this opinion, with the text to be redacted blacked
out.
10
IT IS SO ORDERED.
s/Patricia E. Campbell-Smith
PATRICIA E. CAMPBELL-SMITH
Judge
11