stating that medical opinion evidence is required to support an on- Table theory where medical records fail to establish a Table injury
How later courts described this case
- stating that medical opinion evidence is required to support an on- Table theory where medical records fail to establish a Table injury
Written by the judges who cited it.
The opinion
In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 15-1013V
************************* *
*
LYNSIE KAMPPI, *
* TO BE PUBLISHED
*
Petitioner, *
* Special Master Katherine E. Oler
v. *
*
* Filed: November 6, 2020
SECRETARY OF HEALTH AND *
HUMAN SERVICES, * Attorneys’ Fees and Costs; Reasonable
*
* Basis
Respondent. *
*
************************* *
Braden Blumenstiel, The Law Office of DuPont & Blumenstiel, Dublin, OH, for Petitioner.
Linda Renzi, U.S. Department of Justice, Washington, DC, for Respondent.
DECISION ON FINAL ATTORNEYS’ FEES AND COSTS1
On September 14, 2015, Lynsie Kamppi (“Ms. Kamppi” or “Petitioner”) filed a petition
for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-
10, et seq.2 (the “Vaccine Act” or “Program”) alleging she developed Guillain-Barré syndrome
(“GBS”) from the influenza (“flu”) vaccination she received on September 28, 2013. Pet. at 1,
ECF No. 1.
Because I find the petition did not possess a reasonable basis when it was filed or at any
time during the pendency of this case, I hereby DENY Petitioner’s application for attorneys’ fees
and costs.
1
This Decision will be posted on the United States Court of Federal Claims’ 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 in 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. To do so, each party
may, within 14 days, 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, this Decision will be available to the public in its present 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. 3755 (codified as amended at 42 U.S.C. §§ 300aa-10–34 (2012)) (hereinafter
“Vaccine Act” or “the Act”). All subsequent references to sections of the Vaccine Act shall be to the
pertinent subparagraph of 42 U.S.C. § 300aa.
1
I. Petitioner’s Relevant Medical History
A. Petitioner’s Medical History Prior to the Flu Vaccination
Petitioner had a history of irritable bowel syndrome and gastroparesis. Ex. 2 at 35. On
January 18, 2014, Petitioner told Dr. Steven Simensky that she traveled to Bakersfield, California
after receiving her flu vaccination. Ex. 3 at 19. While in California, Petitioner stated she was
“surrounded by a pandemic of H1N1 flu, which had resulted in several deaths of younger people.”3
Id. In addition, the medical records indicate that Petitioner stated she had developed sinus
symptoms for four days during the prior week (the week of January 5, 2014).4 Id. at 20.
B. The Flu Vaccination and Petitioner’s Subsequent Medical History
Petitioner received a flu vaccine on September 28, 2013. Ex. 7 at 1. Petitioner next sought
medical care on November 19, 2013. Ex. 2 at 29. On that date, she visited Dr. Robert Sears, her
primary care physician (“PCP”), for a routine follow-up appointment to address hypoglycemia,
anxiety, and depression. Id. The physician’s notes from that visit indicate that Petitioner recently
began taking a new medication for depression, and that she was responding well to that medication.
Id. at 29-30. The notes further indicate that Petitioner was “getting some hypoglycemic episodes
[which occur] around 10:30am.” Id. at 29. The notes did not reflect any mention of Petitioner
experiencing numbness, tingling, or pain in her legs. Id.
Petitioner did not seek medical care again until January 17, 2014, when she presented to
OhioHealth Urgent Care complaining of “decreased mobility, joint tenderness, numbness, tingling
in the legs and weakness.” Ex. 15 at 1. The patient notes signed by Dr. Ebunoluwa Wion further
indicate that onset began “2 days ago” and that Petitioner experienced “sudden onset of leg pain
with pins/needles sensation and heaviness x2 days now.” Id. The notes do not indicate that
Petitioner mentioned experiencing previous symptoms of pain, numbness, and tingling back in
October and November 2013 to Dr. Wion at this urgent care visit. Id.
After her urgent care visit, Petitioner was referred to the emergency room on that same
day, where she was evaluated by Dr. Mark Renz. Ex. 3 at 15. The patient history indicates as
follows:
On 1/15/20135 patietn [sic] developed left calf pain and numbness/tingling in her
LLE. By the next morning this had resolved. Starting 1/17 patient developed
recurrent LLE numbness/tingling, left calf pain, and weakness to the LLE. By the
3
Petitioner adamantly denies making this statement. Tr. at 121-22.
4
Petitioner also denies making this statement and avers that she did not have any type of illness during this
timeframe. Tr. at 117-20.
5
Although the medical history indicates Petitioner’s condition began in 2013, this appears to be a
typographical error, and should instead state “2014”.
2
afternoon patient developed numbness/tingling to the RLE, pain to the right calf,
and weakness of the RLE.
Id. The ER patient notes do not reference any numbness, pain, or tingling that began prior to
January 15, 2014. Id.
On January 18, 2014, Dr. Steven Simensky (a neurologist) evaluated Petitioner. The
“Assessment and Plan/Recommendations” from this visit stated that Petitioner “presents with 3
days h/o rapidly progressive, ascending paresthesias and weakness.…MRI and L-spine normal,
LP with normal protein probably d/t early course of disease. The disease nadir is approximately
7-14 days.” Ex. 3 at 19. The notes under “History [o]f Present Illness” stated,
32 yo healthy GMC nurse with h/o IBS, gastroparesis, chronic diarrhea presents to
GMC with a 3 d y/o progressive LE weakness. Pt states that she received the
influenza shot approximately 7 weeks ago6 without complications, later travelled
to Bakersfield, CA for a family emergency and was surrounded by a pandemic of
H1N1 flu.…She also developed sinus sx x 4 days last week. She was in this state
when on 3 days prior to admission, she developed transient left calf
numbness/tingling/pain which resolved until yesterday. At that point, her left leg
sx recurred along with leg weakness and quickly thereafter, affected her right leg.
Id. at 19-20. There is no indication in the notes from this visit that Petitioner mentioned
experiencing previous symptoms of pain, numbness, and tingling back in October and November
2013 when speaking with Dr. Simensky. Id.
On January 18, 2014, Dr. Paul Willette examined Petitioner and took her medical history.
Ex. 3 at 40. In his notes, he wrote, “This is a very pleasant 32-year-old female who is an L and D
nurse here at Grant. She became sick in the past couple of days…. Her symptoms began
Wednesday7[,] Thursday she states she was not that bad, and today at 4:00 her symptoms
progressed.” Id. The notes do not reflect that Petitioner mentioned experiencing previous
symptoms of pain, numbness, and tingling in October and November 2013 to Dr. Willette. Id.
On January 19, 2014, Petitioner was treated by Dr. George Connell, an anesthesiologist.
Ex. 3 at 22. In recording Petitioner’s history, Dr. Connell documented “[s]ymptoms started several
days ago now with sensory and motor loss to both lower extremities, left upper extremity
weakness.” Id. There is no indication that Petitioner mentioned experiencing previous symptoms
of pain, numbness, and tingling back in October and November 2013 to Dr. Connell. Id.
On January 21, 2014, Dr. Julian Goodman, an infectious disease physician, treated
Petitioner and documented that “last Wednesday started getting some numbness in her calf which
fairly quickly progressed into LE weakness and progressive ascending paresis and diagnosed with
GBS.” Id. at 30. The notes do not reflect that Petitioner mentioned experiencing previous
6
Ex. 7 clearly indicates that Petitioner received her flu vaccination on September 28, 2013, which was 113
days or three months and 22 days before the date she was admitted to the ER.
7
January 15, 2014 was a Wednesday.
3
symptoms of pain, numbness, and tingling back in October and November 2013 to Dr. Goodman.
Id.
On January 27, 2014, Dr. Nicole Burns treated Petitioner. Ex. 3 at 34. When drafting the
history of Petitioner’s present illness, she wrote, “[o]n 1/15 she developed LLL numbness and
tingling that resolved by the next morning. Then on 1/17 she again developed recurrent left sided
numbness and tingling. She presented when she noticed symptoms on her right side as well with
difficulty walking and writing.” Id. at 34-35. The notes do not reflect that Petitioner related
previous symptoms of pain, numbness, and tingling back in October and November 2013 to Dr.
Burns. Id.
Petitioner was discharged from Grant Medical Center on January 28, 2014 and was
admitted to the OhioHealth Institute for Rehabilitation on that same day. Ex. 3 at 37-38. The
OhioHealth Institute for Rehabilitation took Petitioner’s medical history upon her admission and
documented this history in her medical records. According to these records, “[s]he experienced
an episode of numbness, tingling in her left leg on January 15, 2014, and did not pay much attention
to it and thought maybe it was some type of musculoskeletal issue and it resolved the next morning
but then it returned again in a much worse fashion on January 17, 2014, where the patient had
difficulty walking and riding, and she was sent to the hospital from urgent care evaluation.” Ex.
4 at 1. During intake at the rehabilitation facility on January 28, 2014, there is no indication that
Petitioner mentioned experiencing previous symptoms of pain, numbness, and tingling in October
and November 2013. Id.
Additional medical records were submitted but are not relevant to this Decision.
II. Procedural History
On September 14, 2015, Petitioner filed a petition alleging that she suffered from GBS as
a result of a flu vaccination administered on September 28, 2013. Pet., ECF No. 1. Petitioner filed
medical records on October 2, 2015 and February 26, 2016. ECF Nos. 8, 12.
On April 12, 2016, Respondent filed a Rule 4(c) Report stating that “[P]etitioner has failed
to demonstrate entitlement to compensation and her petition for compensation should be
dismissed.” ECF No. 17.
Petitioner filed affidavits on September 20, 2016, October 12, 2016, and November 11,
2016. Exs. 10-14. She then filed additional medical records on February 15, 2017. Exs. 15-20.
The parties appeared for a telephonic status conference before former Special Master
Hastings on March 22, 2017. ECF No. 43. Special Master Hastings informed the parties of his
retirement and explained that scheduling further proceedings in this case was not appropriate until
a new special master was appointed. Id. Scheduling an onset hearing was also discussed, and
Special Master Hastings noted that “based on [his] review of the relevant medical records, it
appear[ed] that there [was] no support in those records for Petitioner’s allegations concerning the
time of onset of Petitioner’s injury.” Id. at 1. Special Master Hastings “advised counsel that, in
such circumstances, it may be difficult for the new special master to find that there existed a
reasonable basis to proceed with this case.” Id.
4
This case was reassigned to Special Master Corcoran on October 5, 2017. ECF No. 48.
This case was subsequently reassigned to me on December 5, 2017. ECF No. 50.
I held a status conference on December 21, 2017 to discuss the next steps in this case. ECF
No. 51. During the status conference, Respondent noted that a fact hearing was not necessary, and
questioned reasonable basis. Id. Petitioner’s counsel emphasized that the affidavits support
Petitioner’s alleged date of onset and further suggested that Petitioner and her witnesses be
afforded the opportunity to testify at the hearing. Id.
I held a fact hearing on March 23, 2018 in Washington, DC to determine the date of onset
of Petitioner’s GBS. I issued my ruling on onset on April 26, 2018. In that ruling, I found that
Petitioner did not begin to experience symptoms associated with GBS until January 15, 2014. See
Ruling on Onset at 2, ECF No. 59. I directed Petitioner to either file an expert report supporting
onset of GBS symptoms 15 weeks and five days after flu vaccination or a status report indicating
how she intended to proceed. Id.
On June 11, 2018, Petitioner filed her first request for a continuance, requesting a 30-day
extension of time to “obtain an expert report linking [P]etitioner’s vaccine to her injury with a date
of onset beginning January 15, 2014.” See ECF No. 61 at 1. I granted that Motion on June 13,
2018 and ordered Petitioner to file her expert report by July 11, 2018. See non-PDF Order on
6/13/2018. In that Order, I also directed Petitioner to request a status conference if she was unable
to timely file her expert report. Id.
On July 11, 2018, in lieu of filing her expert report, Petitioner filed a status report
requesting a status conference. See ECF No. 62. In that status report, Petitioner represented that
an expert had been provided with the necessary materials, and that a report would be produced
within the next three to six weeks.8 Id.
I held a status conference on August 13, 2018, primarily to discuss Petitioner’s efforts to
obtain an expert report in this case. See Minute Entry on 8/13/2018; see also Scheduling Order on
8/13/2018, ECF No. 63. At that time, Petitioner’s counsel represented that an expert report was
now expected within three weeks. Respondent again questioned whether there was a reasonable
basis for Petitioner’s claim. See Scheduling Order on 8/13/2018, ECF No. 63. I informed
8
Specifically, Petitioner represented the following regarding her counsel’s progress in procuring an expert
report:
Petitioner has submitted materials to an expert and notified the expert of Special Master
Oler’s Ruling on Onset determination that [P]etitioner first experienced symptoms on
January 15, 2014. Counsel for [P]etitioner has notified the expert that any opinions must
be based on the Ruling that the symptoms first began on January 15, 2014. Counsel for
[P]etitioner has been informed a report will likely be available within 3 to 6 weeks.
ECF No. 62 at 1. Thus, I note that, as of the date of Petitioner’s status report of July 11, 2018, Petitioner
and her counsel represented to the Court that Petitioner will file her expert report by August 22, 2018, i.e.,
six weeks after her status report.
5
Petitioner’s counsel that, in light of my Ruling, I also questioned whether there was a reasonable
basis to proceed in this case. See id. Additionally, I expressed my concerns to Petitioner’s counsel
that “Petitioner does not have a reasonable likelihood of proving a medically appropriate temporal
relationship of 15 weeks and five days between [Petitioner’s] vaccination and onset of [her] GBS.”
Id. at 1.9 Moreover, I relayed to Petitioner’s counsel that there has not been a successful case in
the Program to hold that such a lengthy time frame between vaccination and onset of GBS is
medically reasonable to support causation. Id. Nonetheless, I granted Petitioner’s second
extension of time, ordering Petitioner to now file her expert report or status report by October 15,
2018. Id.
On October 15, 2018, Petitioner filed a status report requesting a third extension of time.
See Status Rep. on 10/15/2018, ECF No. 64. In that status report, Petitioner again represented that
an expert has been contacted, and a report should be available in four weeks. In response to
Petitioner’s status report (ECF No. 64), I issued an Order granting Petitioner’s third request for an
extension of time. ECF No. 65. In that Order, I detailed Petitioner’s numerous attempts to produce
an expert opinion that supports onset of GBS following flu vaccination at 15 weeks and five days.
Id. I further clarified that no further extensions of time would be entertained and that, if Petitioner
does not file her expert report, an order to show cause would be issued. Id.
On November 15, 2018, Petitioner filed her fourth request for an extension of time.10 See
Mot. for Extension on 11/15/2018, ECF No. 66. In that Motion, Petitioner represented that she
was in possession of medical literature and a medical literature review conducted by Dr. James
Lyons-Weiler. Id. Petitioner claimed, however, that the expert report from Dr. Lyons-Weiler had
not been signed and that Petitioner required until December 15, 2018, to obtain the signed report.
Id. Petitioner further represented that she had not previously filed a motion for enlargement of
time with regard to this matter. Id.
On November 16, 2018, following the informal communications conducted between
chambers and the parties, Petitioner filed two documents labeled as “Expert Reports of Dr. James
Lyons-Weiler.” See ECF No. 67, 68. After reviewing the documents, I notified the parties that a
status conference was necessary in order to determine Petitioner’s next steps.
I held a status conference that same day, on November 16, 2018. See Minute Entry on
11/16/2018. During that status conference, I allowed Respondent’s counsel to comment on the
documents filed by Petitioner that day. See Scheduling Order on 11/16/2018, ECF No. 70. As
articulated thoroughly in my Order filed on November 16, 2018, Respondent did not view the
documents to be at the substantive level of expert reports or to address a causation theory. Id.
When given an opportunity to respond, Petitioner’s counsel agreed that these were not expert
9
During that status conference, I also told Petitioner’s counsel that if Petitioner is unable to obtain an expert
report, Petitioner’s counsel shall “show this Order to Petitioner and discuss dismissal of the petition.” ECF
No. 63 at 1.
10
Petitioner further added that “Petitioner has not been able to communicate with counsel for respondent
with regard to this request, but will reach out to her as soon as possible.” ECF No. 66. Respondent’s counsel
informed chambers, through informal communications that he had not been contacted by Petitioner or
notified of the Motion (ECF No. 66).
6
reports and did not address the issue of onset. Id. Petitioner’s counsel added that he was aware
the documents would “not have a huge impact” on the prosecution of the claim but filed them since
they were the only evidence Petitioner was able to produce. Id.
I informed Petitioner’s counsel that I did not view the documents to be adequate medical
literature reviews and noted that no literature had been filed in support of the claim. See
Scheduling Order on 11/16/2018. I further impressed upon Petitioner’s counsel that, given the
insurmountable issue of onset in this case, Petitioner should move to dismiss her claim. Id. I
directed Petitioner’s counsel to speak with Petitioner regarding the dismissal of the claim and file
a status report by November 26, 2018, indicating how she wished to proceed. Id.
Petitioner did not file her status report on November 26, 2018, as directed, but on
November 27, 2018, filed a request for an extension of time to file her status report. See ECF No.
71. Petitioner represented that she had spoken with her counsel, and that she directed her counsel
to conduct further research regarding the issue of GBS onset. Id. Petitioner stated that she would
consider dismissal of the claim only after her counsel had presented her with this research. Id. I
granted Petitioner’s request for an extension. ECF No. 72. In that Order, I included references to
cases decided by this Court in which several Special Masters found varying lengths of time in
excess of 42 days to be medically infeasible onset time frames for GBS following flu vaccination.
Id. Petitioner’s status report was due November 30, 2018. Id.
Petitioner did not file her status report on November 30, 2018; instead on December 4,
2018, Petitioner filed a second request for an extension of time to file her status report. ECF No.
73. In that Motion, Petitioner stated that her counsel had provided her with the relevant case law
regarding the issue of onset and that they were scheduled “to speak yesterday about how
[P]etitioner would like to proceed.”11 Id. Because Petitioner had several opportunities to consider
her position since my Ruling on Onset in April of 2018 and had been unable to produce evidence
supporting GBS onset 15 weeks and five days post-vaccination, I did not grant this request for an
extension of time and instead issued an Order to Show Cause as to why her petition should not be
dismissed. ECF No. 74.
Petitioner responded to the Order to Show Cause on January 3, 2019. ECF No. 75.
Respondent replied on February 13, 2019. ECF No. 76.
I held a status conference with the parties on February 15, 2019. During that status
conference, I informed Respondent that I wanted him to file an expert report addressing the
feasibility of onset of GBS 15 weeks and five days after flu vaccine. Respondent submitted a
report by Dr. J. Lindsay Whitton entitled “Review of the causes of GBS, with particular attention
to influenza vaccines.” Ex. A. (hereinafter “Whitton Rep.”). Respondent filed Dr. Whitton’s CV
as Ex B.
On April 26, 2019, the parties each filed a status report indicating their agreement that I
decide this case on the record. ECF Nos. 80, 81. Through informal communications on June 17,
2019, the parties were asked if they required an additional briefing schedule. Respondent replied
11
Petitioner represents that she was scheduled to speak with counsel regarding the status report on
December 3, 2018, which was three days after her most recent deadline. ECF No. 73.
7
that they did not intend to submit a brief. On June 30, 2019, Petitioner filed a status report, stating
that she did not require a briefing schedule. ECF No. 82.
I issued a Decision Denying Entitlement on July 24, 2019. See Kamppi v. Sec’y of Health
& Human Servs., No. 15-1013, 2019 WL 5483161 (Fed. Cl. Spec. Mstr. Jul. 24, 2019). Judgment
was entered on August 29, 2019. ECF No. 86. On February 2, 2020, Petitioner filed an application
for attorneys’ fees and costs, totaling $28,611.99. Counsel for Petitioner Lynsie Kamppi’s Motion
for Fees and Expenses (hereinafter “Fees Application” or “Fees App.”) at 2, ECF No. 88. On
March 9, 2020, Respondent filed a response stating, “[P]etitioner has not demonstrated that the
claim was supported by a reasonable basis” and “therefore respectfully requests that [I] deny
[P]etitioner’s motion.” Fees Resp. at 1, ECF No. 90. Petitioner filed a Reply on April 10, 2020
which reiterated many points previously addressed in support of entitlement. Fees Resp., ECF No.
92. This matter is now ripe for adjudication.
III. Legal Standard
Under the Vaccine Act, an award of reasonable attorneys’ fees and costs is presumed where
a petition for compensation is granted. Where compensation is denied, or a petition is dismissed,
as it was in this case, the special master must determine whether the petition was brought in good
faith and whether the claim had a reasonable basis. § 15(e)(1).
A. Good Faith
The good faith requirement is met through a subjective inquiry. Di Roma v. Sec’y of Health
& Human Servs., No. 90-3277V, 1993 WL 496981, at *1 (Fed. Cl. Spec. Mstr. Nov. 18, 1993).
Such a requirement is a “subjective standard that focuses upon whether [P]etitioner honestly
believed he had a legitimate claim for compensation.” Turner v. Sec’y of Health & Human Servs.,
No. 99-544V, 2007 WL 4410030, at *5 (Fed. Cl. Spec. Mstr. Nov. 30, 2007). Without evidence
of bad faith, “petitioners are entitled to a presumption of good faith.” Grice v. Sec’y of Health &
Human Servs., 36 Fed. Cl. 114, 121 (1996). Thus, so long as Petitioner had an honest belief that
his claim could succeed, the good faith requirement is satisfied. See Riley v. Sec’y of Health &
Human Servs., No. 09-276V, 2011 WL 2036976, at *2 (Fed. Cl. Spec. Mstr. Apr. 29, 2011) (citing
Di Roma, 1993 WL 496981, at *1); Turner, 2007 WL 4410030, at *5.
B. Reasonable Basis
Unlike the good-faith inquiry, an analysis of reasonable basis requires more than just a
petitioner’s belief in his claim. Turner, 2007 WL 4410030, at *6-7. Instead, the claim must at
least be supported by objective evidence -- medical records or medical opinion. Sharp-Roundtree
v. Sec’y of Health & Human Servs., No. 14-804V, 2015 WL 12600336, at *3 (Fed. Cl. Spec. Mstr.
Nov. 3, 2015).
While the statute does not define the quantum of proof needed to establish reasonable basis,
it is “something less than the preponderant evidence ultimately required to prevail on one’s
vaccine-injury claim.” Chuisano v. United States, 116 Fed. Cl. 276, 283 (2014). The Court of
Federal Claims affirmed in Chuisano that “[a]t the most basic level, a petitioner who submits no
8
evidence would not be found to have reasonable basis….” Id. at 286. The Court in Chuisano
found that a petition which relies on temporal proximity and a petitioner’s affidavit is not sufficient
to establish reasonable basis. Id. at 290. See also Turpin v. Sec'y Health & Human Servs., No. 99-
564V, 2005 WL 1026714, *2 (Fed. Cl. Spec. Mstr. Feb. 10, 2005) (finding no reasonable basis
when petitioner submitted an affidavit and no other records); Brown v. Sec'y Health & Human
Servs., No. 99-539V, 2005 WL 1026713, *2 (Fed. Cl. Spec. Mstr. Mar. 11, 2005) (finding no
reasonable basis when petitioner presented only e-mails between her and her attorney). The
Federal Circuit has affirmed that “more than a mere scintilla but less than a preponderance of proof
could provide sufficient grounds for a special master to find reasonable basis.” Cottingham v.
Sec’y of Health & Human Servs., No. 2019-1596, 971 F.3d 1337, 1346 (Fed. Cir. Aug. 19, 2020)
(finding Petitioner submitted objective evidence supporting causation when she submitted medical
records and a vaccine package insert).
Temporal proximity between vaccination and onset of symptoms is a necessary component
in establishing causation in non-Table cases, but without more, temporal proximity alone “fails to
establish a reasonable basis for a vaccine claim.” Chuisano, 116 Fed. Cl. at 291.
The Federal Circuit has stated that reasonable basis “is an objective inquiry” and concluded
that “counsel may not use [an] impending statute of limitations deadline to establish a reasonable
basis for [appellant’s] claim.” Simmons v. Sec’y of Health & Human Servs., 875 F.3d 632, 636
(Fed. Cir. 2017). Further, an impending statute of limitations should not even be one of several
factors the special master considers in her reasonable basis analysis. “[T]he Federal Circuit
forbade, altogether, the consideration of statutory limitations deadlines—and all conduct of
counsel—in determining whether there was a reasonable basis for a claim.” Amankwaa v. Sec’y
of Health & Human Servs., 138 Fed. Cl. 282, 289 (2018). Objective medical evidence, including
medical records, can constitute evidence of causation supporting a reasonable basis. Cottingham,
971 F.3d at 1346.
“[I]n deciding reasonable basis the [s]pecial [m]aster needs to focus on the requirements
for a petition under the Vaccine Act to determine if the elements have been asserted with sufficient
evidence to make a feasible claim for recovery.” Santacroce v. Sec’y of Health & Human Servs.,
No. 15-555V, 2018 WL 405121, at *7 (Fed. Cl. Jan. 5, 2018). Special masters cannot award
compensation “based on the claims of petitioner alone, unsubstantiated by medical records or by
medical opinion.” 42 U.S.C. § 300aa-13(a)(1). Special masters and judges of the Court of Federal
Claims have interpreted this provision to mean that petitioners must submit medical records or
expert medical opinion in support of causation-in-fact claims. See Waterman v. Sec'y of Health &
Human Servs., 123 Fed. Cl. 564, 574 (2015) (citing Dickerson v. Sec'y of Health & Human Servs.,
35 Fed. Cl. 593, 599 (1996) (stating that medical opinion evidence is required to support an on-
Table theory where medical records fail to establish a Table injury)).
When determining if a reasonable basis exists, many special masters and judges consider
a myriad of factors. It is appropriate to analyze reasonable basis through a totality of the
circumstances test that focuses on objective evidence. Cottingham, 971 F.3d at 1344. The factors
to be considered may include “the factual basis of the claim, the medical and scientific support for
the claim, the novelty of the vaccine, and the novelty of the theory of causation.” Amankwaa, 138
Fed. Cl. at 289. This approach allows the special master to look at each application for attorneys’
9
fees and costs on a case-by-case basis. Hamrick v. Sec’y of Health & Human Servs., No. 99-683V,
2007 WL 4793152, at *4 (Fed. Cl. Spec. Mstr. Nov. 19, 2007).
IV. Parties’ Arguments
Respondent argues that “Petitioner has failed to establish a reasonable basis for her claim,
and is thus not entitled to an award of attorneys’ fees and costs.” Fees Resp. at 6. Respondent
notes that a claim must “at a minimum, be supported by medical records or medical opinion.” Fees
Resp. at 7; Everett v. Sec’y of Health & Hum. Servs., No. 91-1115V, 1992 WL 35863, at *2 (Cl.
Ct. Spec. Mstr. Feb. 7, 1992). Respondent argues that although a hearing to determine onset was
held, it was determined that onset of GBS occurred 15 weeks and five days after vaccination, which
“put [P]etitioner on notice that she was likely proceeding without a reasonable basis.” Id. at 8.
Although Petitioner was given the opportunity to file an expert report, Petitioner was also aware
that she was “proceeding at her own risk.” Id.; see generally ECF Nos. 63, 70, 74. Respondent
also claims that “the filings of Dr. Lyons-Weller’s [sic] reports emphasize that after four years,
and with countless extensions, [P]etitioner could not find an expert to opine on causation.” Fees
Resp. at 8.
Petitioner argues that when the Petition was filed, Ms. Kamppi stated, “Within a few weeks
of receiving the flu vaccine” she experienced a wide variety of symptoms associated with her lower
extremities and some numbness and tingling in her upper extremities. Ex. 1 at 1. Eventually, in
mid-January, her symptoms required medical attention and that is when she received the diagnosis
of GBS. Fees Reply at 6. A few of Petitioner’s doctors noted in her medical records that her GBS
might have been secondary to the flu vaccination that she received previously.12 See Fees App. at
2, ECF No. 88. Petitioner filed affidavits that stated that Petitioner’s symptoms began in October
2013, which was in the temporal window for the onset of GBS after a flu vaccination. Petitioner
also filed two reports from Dr. Lyons-Weiler, and Respondent filed an expert report by Dr. Whitton
regarding the feasibility of onset of GBS 15 weeks and five days post-vaccination. Petitioner
argues that the filing of Dr. Whitton’s expert report was necessary to resolving this case, thus
Petitioner had reasonable basis until the issue of causation was resolved. Fees Reply at 8-9.
Petitioner argues that the factual issue of onset remained disputed until I issued a Decision
on July 24, 2019, thus until that was decided, Petitioner had reasonable basis for filing her claim.
Fees Reply at 8.
V. Discussion
A. Good Faith
Petitioners are entitled to a presumption of good faith. See Grice, 36 Fed. Cl. 114 at 121.
Respondent does not challenge Petitioner’s good faith. See Fees Resp. at 6, n. 6. Based on my
own review of the case, I find that Petitioner acted in good faith when filing this petition.
B. Reasonable Basis
12
However, these notations also indicate that the physicians erroneously believed Petitioner received the
vaccination seven weeks prior to her January 2014 hospitalization.
10
As noted above, the standard for establishing reasonable basis is lower than that required
to prevail on a vaccine-injury claim. Chuisano, 116 Fed. Cl. 276 at 287. However, Petitioner is
still required to provide some evidence that her injury was caused by the flu vaccination she
received.
1. The Fact that I Ordered Respondent to file an Expert Report does not Establish
Reasonable Basis
Petitioner argues that the filing of Dr. Whitton’s expert report was necessary to resolving
this case, thus Petitioner had reasonable basis until the issue of causation was resolved. Fees Reply
at 8-9. However, the Federal Circuit has made it clear that the reasonable basis analysis centers
around whether Petitioner has presented objective evidence supporting the petition. My request
that Respondent submit an expert report is not objective evidence. Instead, the appropriate analysis
must focus on whether the evidence Petitioner actually presented during the pendency of her claim
constitutes objective evidence sufficient to meet her burden (“more than a mere scintilla but less
than a preponderance of proof”). Cottingham, 971 F.3d at 1346. As discussed below, I find that
it does not.
2. The Medical Records do not Establish Reasonable Basis
Petitioner’s medical records surrounding her GBS diagnosis are clear, internally consistent,
and complete. She received her vaccine on September 28, 2013 and presented to her primary care
provider in November of 2013 with unrelated medical issues. There is no mention of numbness
or tingling at that visit. Ex. 2 at 29. She spoke with nine different medical providers between
November 2013 and January 2014. There is no reference in those records to onset of pain,
numbness, or tingling that began in October or November of 2013 (as is articulated in the affidavits
and the testimony at the onset hearing). Instead, each of those medical providers consistently
documented that Petitioner began experiencing symptoms of GBS on January 15, 2014. 13 Based
on these medical records, Petitioner began to experience onset of GBS on January 15, 2014, more
than 15-and-one-half weeks after she received her flu vaccination.
While there are medical records which indicate that Petitioner’s GBS might have been
caused by the flu vaccination, it is clear that Petitioner’s physicians erroneously believed that she
13
See Ex. 2 at 29 (medical visit on November 19, 2013 where Petitioner does not mention symptoms of
GBS); Ex 15 at 1 (urgent care visit on January 17, 2014 where Petitioner describes numbness, tingling and
weakness in the legs with onset “2 days ago”); Ex. 3 at 15 (ER visit on January 17, 2014 which indicates
that Petitioner developed left calf pain and numbness and tingling on January 15, 2014); Ex. 3 at 19
(neurology evaluation on January 18, 2014 which notes three day history of rapidly progressive ascending
paresthesias and weakness); Ex. 3 at 40 (medical examination noting that Petitioner became sick on
Wednesday (which was January 15, 2014)); Ex. 3 at 22 (medical visit with an anesthesiologist on January
19, 2014 noting sensory and motor loss to both extremities which “started several days ago.”); Ex. 3 at 30
(January 21, 2014 record from an infectious disease physician who noted that Petitioner’s numbness and
progression of symptoms began last Wednesday); Ex. 3 at 34-35 (doctor who notes numbness and tingling
that began on January 15); Ex. 4 at 1 (rehabilitation records which describe an initial episode of numbness
and tingling on January 15, 2014).
11
received the flu vaccine seven weeks prior to symptom onset.14 Because these opinions were based
on an inaccurate premise, I do not find that they constitute evidence which establishes reasonable
basis.
3. Petitioner’s Affidavits/Testimony do not Establish a Reasonable Basis
Petitioner filed affidavits from herself, her husband, her mother, and two co-workers. Exs.
10-14. The testimony at the onset hearing was largely consistent with these affidavits. Neither
the affidavits submitted in this case nor the testimony provide Petitioner with reasonable basis.
Each affidavit stated that Petitioner began to experience numbness and tingling in her legs in the
October 2013 timeframe, but no objective piece of evidence supports this assertion. In fact, all of
the medical records contradict these claims.
Furthermore, Petitioner and her co-workers stated that Petitioner missed work in “late
2013” or “December 2013” because of her alleged symptoms, however Petitioner’s work
attendance records show that Petitioner did not miss any work during that period. See Ex. 12 at 1
(“[Petitioner] informed me that she was being reprimanded by her supervisor for missing too many
days of work”), Ex. 13 at 1 (“I recall that Lynsie called off from work numerous times in late
2013”; “I recall Lynsie getting called into the office by her supervisor for the numerous absences
she had accumulated in 2013”), Ex. 14 at 4 (“Also in November, I was becoming exceedingly
fatigued. In fact, I was calling off work due to exhaustion and symptoms I was experiencing,
especially those in my legs”); contra Ex. 16 at 30-32 (showing Petitioner missed no time from
work from August 2013-December 2013).
In addition, the description of onset that is detailed in the affidavits and testimony is
inconsistent with the medically recognized progression of GBS. GBS is an acute disease and does
not take months to manifest. As Dr. Whitton stated in his report, “By definition, in GBS the
maximum weakness occurs within 4 weeks of onset”. Whitton Rep. at 2 (emphasis added). He
went on to state that “[i]n practice, most GBS patients reach maximum weakness within 2 weeks
of disease onset.” Id. Four weeks from October 22, 2013 (the date Petitioner stated in her second
affidavit that her symptoms began) is November 19, 2013. It is clear from the medical records
that Petitioner’s maximum weakness occurred nearly two months after this – in mid-January 2014.
Although the Federal Circuit’s decision in Cottingham did not address whether affidavits
standing alone could confer reasonable basis, I find that when they are wholly inconsistent with
the medical records and other evidence filed on the issue of onset and with the medically
recognized disease progression, as they are in this case, they do not provide Petitioner with a
reasonable basis. Based on the records filed in this case, I do not find that Petitioner has submitted
objective evidence to establish reasonable basis in support of her claim.
14
See Ex. 3 at 19, 59, 68, 71, 78, 88 (medical history collected by Dr. Steven Simensky stating “32 yof h/o
IBS with chronic diarrhea, gastroparesis, with flu shot 7 weeks ago…”); id. at 24 (“1) Guillain Barre
Syndrome – 357.0: Clinical picture very consistent with this; ? secondary to influenza vaccine ~ 7 weeks
ago” written by Dr. LeRoy Essig); id. at 62, 81 ((“1) Guillain Barre Syndrome – 357.0: Clinical picture
very consistent with this; ? secondary to influenza vaccine ~ 7 weeks ago” by Dr. Blake Conklin (same as
Dr. LeRoy Essig)); id. at 91, 96 (Dr. Simensky’s medical history copied by Dr. Emily Klatte); Ex. 4 at 41,
47, 104, 121, 124, 176, 365 (“Mrs. Kamppi had the flu shot 7 weeks ago,” taken by Robert Hall).
12
3. Dr. Lyons-Weiler’s Documents do not Establish a Reasonable Basis
a. Dr. Lyons-Weiler’s Qualifications
Petitioner submitted two documents from Dr. James Lyons-Weiler. Exs. 21-22. No
curriculum vitae was submitted for Dr. Lyons-Weiler, however, because he has provided an
opinion in other cases before the Court, I am familiar with his credentials. Dr. Lyons-Weiler has
a master’s degree in Zoology and a Ph.D. in ecology, evolution, and conservation biology. Dr.
Lyons-Weiler is not a medical doctor. See A.S. v. Sec’y of Health & Human Servs., No. 16-551,
2019 WL 5098964 at *5 (Fed. Cl. Spec. Mstr. Aug. 27, 2019). In terms of Dr. Lyons-Weiler’s
educational background and experience, Chief Special Master Corcoran has found that Dr. Lyons-
Weiler is unqualified to opine on vaccine causation. See id. at *11. In this same case, Chief
Special Master Corcoran found that there was no reasonable basis for Petitioner to file the petition
alleging that multiple vaccines caused Petitioner to develop neurologic neglect syndrome,
expressive language disorder, unspecified disorders of the nervous system, and immune
dysfunction, despite the fact that Petitioner filed expert reports from Dr. Lyons-Weiler. A.S. v.
Sec’y of Health & Human Servs., No. 16-551V, 2020 WL 549443 (Fed. Cl. Spec. Mstr. Jan. 3,
2020)
b. Substance of Dr. Lyons-Weiler’s Documents
Dr. Lyons-Weiler stated that the studies regarding GBS onset are arbitrarily set, typically
at six weeks, but can range from eight to ten weeks as well. Ex. 21 at 1. Dr. Lyons-Weiler further
stated that because the National Vaccine Injury Compensation Program sets the onset window at
six weeks, studies on onset of GBS only consider cases where onset is within six weeks, which
lead to a “self-fulfilling, but still arbitrary, exclusion of cases with onset after six weeks based on
circular reasoning.” Id. Dr. Lyons-Weiler cited two pieces of literature. Neither piece of literature
was filed.
Dr. Lyons-Weiler used data from the CDC (uncited) to state that there are approximately
0.035 GBS cases per 100,000 people per week in the United States. Id. Dr. Lyons-Weiler next
cited a Canadian study that shows that there are 0.03 GBS cases per 100,000 people. Id. Based
on the CDC numbers and the Canadian study, Dr. Lyons-Weiler concluded that the “’control’
intervals in these studies overestimate the null hypothesis parameter value for non-vaccine related
GBS incidence.” Id. Second, Dr. Lyons-Weiler cited a case report of a 52-year old woman who
developed GBS ten weeks after receiving a recombinant hepatitis B vaccine. Id. It is unclear to
me how this case report relates to this case as the onset window was not similar and the case report
also involved a different vaccine.
In Dr. Lyons-Weiler’s second document, he stated, “there exists no scientific or medical
criterion based on any data from any study or studies that support the notion that any cut-off, be it
five, fifteen, or 52 weeks exists in the etiology of GBS following influenza vaccination.” Ex. 22
at 1. He further stated, “This means cases of GBS happen past 15 and 5 weeks but are ASSUMED,
not DETERMINED, to not be due to the vaccine, and my other analysis demonstrates that
13
assumption is not warranted because the late-period GBS rates are, in fact, higher than the
population baseline.” Id.
Dr. Lyons-Weiler’s documents do not state that flu vaccine can cause GBS more than
fifteen weeks later. Further, nothing in Dr. Lyons-Weiler’s documents addresses how GBS can
develop more than 15-and-one-half weeks after flu vaccine.
As I noted in the Decision Denying Entitlement, special masters have not granted
entitlement to a Petitioner who developed GBS more than two months post-vaccination because it
is not medically plausible for the immune response that is a central component of the autoimmune
process resulting in GBS to take this long. Kamppi v. Sec’y of Health & Human Servs., No. 15-
1013, 2019 WL 5483161 at *11 (Fed. Cl. Spec. Mstr. Jul. 24, 2019). The white paper authored by
Dr. Whitton addresses this point. Dr. Whitton discussed the results of the Langmuir et al. study.
This study addressed, amongst others, the following questions: 1) the extent of the causal
relationship between GBS and the 1976 swine influenza vaccine and 2) the periods of time
following vaccination when the risk of developing GBS is increased. Whitton Rep. at 6. Dr.
Whitton stated that the study results indicate that while there was an increased risk of GBS
following vaccination, any detectable risk diminished after four weeks and returned to the baseline
at six to eight weeks. Id. at 9-10. No increased risk of GBS, therefore, was observed after eight
weeks. Id.
The onset of GBS in this case was well outside the two-month window where medical
experts indicate there is a risk following vaccination, and as a result, where special masters have
found that the flu vaccine can cause GBS. There must be some period of time between vaccination
and onset of signs/symptoms that is per se too long in order for the petition to possess a reasonable
basis. Under the circumstances of this case, I find that more than 15-and-one-half weeks
constitutes a large enough temporal gap that it deprives the petition of reasonable basis.
VI. Conclusion
Based on the foregoing, Petitioner’s Motion for Attorneys’ Fees and Costs is DENIED.
In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the
Court SHALL ENTER JUDGMENT in accordance with this decision.15
IT IS SO ORDERED.
s/ Katherine E. Oler
Katherine E. Oler
Special Master
15
Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party filing a notice
renouncing the right to seek review.
14