Etheridge v. Secretary of Health and Human Services ( 2020 )

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 18-0411V
UNPUBLISHED
AMBER ETHERIDGE, Chief Special Master Corcoran
Petitioner, Filed: October 30, 2020
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Dismissal; Untimely Filed; Onset;
HUMAN SERVICES, Table Injury; Lookback Provision;
Influenza (Flu) Vaccine; Guillain-
Respondent. Barré Syndrome (GBS)
Milton Clay Ragsdale, IV, Ragsdale LLC, Birmingham, AL, for petitioner.
Darryl R. Wishard, U.S. Department of Justice, Washington, DC, for respondent.
DECISION1
On March 19, 2018, Amber Etheridge filed a petition for compensation under the
National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the
“Vaccine Act”). “Petitioner alleges that she incurred Guillain-Barré syndrome due to the
influenza (“flu”) vaccine she received on September 24, 2012, casting her claim as a
Table injury under 42 U.S.C. §300aa-14, as amended effective March 21, 2017.” Petition
at ¶ 7. The case was assigned to the Special Processing Unit of the Office of Special
Masters.
On March 15, 2019, Respondent filed his Rule 4(c) Report, arguing that Petitioner
has failed to establish that her petition was timely filed, or that she suffered the residual
effects of her injury for more than six months. ECF No. 23; see Section 16 (requirements
1
Because this unpublished Decision contains a reasoned explanation for the action in this case, I am
required to post it on the United States Court of Federal Claims' website in accordance with the E-
Government Act of 2002. 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic
Government Services). This means the Decision will be available to anyone with access to the
internet. In accordance with Vaccine Rule 18(b), Petitioner has 14 days to identify and move to redact
medical or other information, the disclosure of which would constitute an unwarranted invasion of privacy.
If, upon review, I agree that the identified material fits within this definition, I will redact such material from
public access.
2
National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755. Hereinafter, for ease
of citation, all section references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
for a timely filed petition); Section 16(c)(1)(D)(i) (statutory six-month requirement).
Accompanying the Rule 4(c) Report was a motion seeking the claim’s dismissal. ECF No.
24. Now, having considered both the motion and Petitioner’s response as well as the
medical records filed in this case, I find that dismissal is appropriate. As discussed in
more detail below, because the claim does not meet the Table requirements for a flu
vaccine/GBS claim, it is untimely under the Act’s “lookback provision” – and even if it had
been timely filed, dismissal would still be appropriate because Petitioner cannot satisfy
the six-month severity requirement applicable to any Vaccine Act claim.
I. Procedural History
After initiation of this case, Petitioner filed documentation showing she received a
flu vaccine on September 24, 2012, as alleged. Exhibit 1, filed Mar. 15, 2019, ECF No. 1-
2. By April 30, 2018, she had filed the medical records she believed were required to
support her claim. Exhibits 2-10, ECF No. 7; Exhibit 11, ECF No. 9; Statement of
Completion, ECF No. 10. The initial status conference was scheduled for May 21, 2018.
During the call, the parties discussed whether Petitioner’s illness qualified as GBS;
whether onset of Petitioner’s illness occurred two days after vaccination, and thus too
soon for a Table GBS; and whether Petitioner had suffered the residual effects of her
illness for more than six months. See Scheduling Order, issued June 7, 2018, ECF No.
11. Petitioner was ordered to file any additional medical records, affidavits, or other
evidence to address these issues. Id. at 2.
Over the subsequent seven-month period, Petitioner filed additional medical
records and affidavits. Exhibits 12-16, filed Sept. 5, 2018, ECF No. 13; Exhibits 17-18,
filed Oct. 16, 2018, ECF No. 16; Exhibits 19-20, filed Jan. 15, 2019, ECF No. 20;
Statement of Completion, filed Jan. 17, 2019, ECF No. 21. On March 15, 2019,
Respondent filed his Rule 4(c) Report, arguing that Petitioner had failed to provide
sufficient evidence to address the deficiencies noted during the initial status conference,
and a motion, requesting that Petitioner’s case be dismissed. ECF Nos. 23-24. In her
response, filed on April 12, 2019, Petitioner argued that Respondent’s motion was
premature and requested that the motion be denied. ECF No. 26.
On August 22, 2019, former Chief Special Master Dorsey3 deferred ruling on
Respondent’s motion to dismiss. Order, issued Aug. 22, 2019, ECF No. 28. She ordered
Petitioner to file an expert report addressing the issues raised by Respondent. Id. at 2.
3
This case was initially assigned to former Chief Special Master Dorsey. On October 1, 2019, I was
appointed Chief Special Master, and the majority of SPU cases, including this one, were reassigned to me.
2
During the subsequent eight-month period, Petitioner attempted to procure an
expert report to establish that her illness met the definition for Table GBS, and that the
effects of her illness had lasted for more than six months. Petitioner first concentrated her
efforts on obtaining a report from one of her treating physicians. E.g., First Motion for
Extension of Time, filed Oct. 23, 2019, at ¶ 1, ECF No. 29. When unsuccessful, Petitioner
attempted to obtain a report from “a specially retained expert.” Third Motion for Extension
of Time, filed Feb. 21, 2020, at ¶ 1, ECF No. 31. By April 21, 2020, Petitioner indicated
her efforts to obtain an expert report had proved unsuccessful. Status Report at ¶ 1, ECF
No. 32. Given the constraints imposed by the COVID-19 pandemic, she requested
additional time to confer with counsel. Id. at ¶ 2. In May and June 2020, Petitioner filed
status reports indicating she still was pursing a report from one of her treating physicians,
Dr. Ennis. ECF Nos. 33-34.
A call was scheduled for July 28, 2020 to discuss Petitioner’s progress. At that
time, Petitioner informed me that she would not be filing an expert report or report of a
treating physician, but still wished to continue with her claim. Order, issued July 31, 2020,
ECF No. 35. In response, it was noted that I had previously determined that the eight-
year lookback period does not apply to non-Table flu-GBS claims,4 but Petitioner stated
that she believed her Table claim did in fact meet the requirements for the claim. Order
at 2. The parties were informed that I intended to rule on the issues raised by Respondent
in his Rule 4(c) Report and motion to dismiss. Deadlines were set for any additional
briefing from the parties.
Petitioner filed her Supplement Brief in Response and Opposition to Respondent’s
Rule 4(c) Report and Motion to Dismiss (“Opp.”) on September 17, 2020. ECF No. 36.
Respondent filed his brief, titled as a Motion for Ruling on the Record, on September 23,
2020. ECF No. 38 (“Mot.”). Because I already had informed the parties that I intended to
rule on the record as it currently stands, the additional deadlines set by Respondent’s
motion were terminated.
II. Ruling on the Record vs Summary Judgment
A threshold issue raised by the parties’ briefs is whether it is appropriate for me to
resolve this matter summarily – and if so, what legal standard should apply.
In her brief, Petitioner reiterates the arguments she made in her initial response
filed in April 2019. Focusing only on the requirements for summary judgment, Petitioner
“contends that her evidence surpasses the low threshold of creating genuine issues of
material fact which must be judged on the merits, and requests that the Court set this
4
See Randolph v. Sec’y of Health & Human Servs., No. 18-1231V, 2020 WL 542735 (Fed. Cl. Spec.
Mstr. Jan. 2, 2020).
3
matter for further proceedings.” Opp. at 4. She maintains that her case “is not appropriate
for dismissal because the Respondent failed to establish the absence of genuine issues
of material fact.” Id. In contrast, Respondent argues that a ruling on the existing record is
appropriate as “[P]etitioner has admittedly filed all documentation and evidence available
in support of her claim.” Res. Brief at 4. He maintains that “[i]n its current state, the record
is completely insufficient to meet [P]etitioner’s burden of proof.” Id.In Section 12(d) of the Vaccine Act, Congress provided guidance regarding the
type of “less-adversarial, expeditious, and informal” proceeding envisioned for the
Vaccine Program. Section 12(d)(2)(A). This guidance was incorporated in the Vaccine
Rules. In Vaccine Rule 3, special masters are instructed “to make the proceedings
expeditious, flexible, and less adversarial, while at the same time affording each party a
full and fair opportunity to present its case and creating a record sufficient to allow review
of the special master’s decision.” Vaccine Rule 3(b)(2). And as explicitly set forth in
Vaccine Rule 8, “[t]he special master may decide a case on the basis of written
submissions without conducting an evidentiary hearing. Submissions may include a
motion for summary judgment, in which event the procedures set forth in RCFC 56 will
apply.” Vaccine Rule 8(d) (emphasis added). Thus, the fact that special masters may
make rulings on the record is a product of the Vaccine Act itself, which envisions efforts
to streamline proceedings in order to reach faster determinations in a less adversarial
manner (especially where the issues that will govern the case’s resolution are narrow or
primarily legal in nature).
As the Federal Circuit explained when recently affirming my decision to rule on the
written record in a different case, a special master’s ability to decide a case based upon
written submissions without a hearing is not limited to the context of summary judgment
as applied by the federal courts and civil procedure rules. Kreizenbeck v. Sec’y of Health
& Human Servs., 945 F.3d 1362, 1366 (Fed. Cir. 2020). Rather, “Rule 8(d) contemplates
that special masters can decide cases on written submissions other than motions for
summary judgment.” Id. (emphasis in original). As explained in Kreizenbeck, special
masters may rule on the record after affording the parties “a full and fair opportunity to
present its case.” Id. (citing Vaccine Rule 3(b)(2)). The “special masters must determine
that the record is comprehensive and fully developed before ruling on the record.”
Kreizenbeck, 945 F.3d at 1366.
In light of the above, Petitioner is incorrect in maintaining that the summary
judgment standards govern the resolution of this matter. Accepting this argument would
limit the special masters’ authority to decide cases based upon written submissions. But
in Kreizenbeck, the Federal Circuit clearly stated that the special masters’ authority is
broader, encompassing the ability to rule on the written without hearing, under standards
distinguishable from those applicable to summary judgment. Rather, I may resolve this
4
case as it stands and on the existing record. The key issue is whether Petitioner has had
a full and fair opportunity to offer evidence in support of her claim.
Although a determination was made earlier in the course of the matter to refrain
from acting on Respondent’s motion – in order to allow Petitioner the chance to develop
the record - those circumstances have changed. As presented in April 2019, Petitioner’s
arguments were enough to warrant deferring a ruling on Respondent’s motion to dismiss,
since she had not yet had the opportunity to fully address the issues raised by
Respondent. However, since that time, Petitioner has been afforded more than a year to
obtain an expert report but has failed to do so. She also could have filed additional
information or evidence bearing on the claim.
Under the Act, a petitioner must demonstrate by preponderant evidence the
requirements for a petition as set forth in section 11(c)(1). Section 13(a)(1)(A). It cannot
be said that resolution of this matter now, on the basis of the existing record, is depriving
Petitioner of the opportunity to prove a matter, since she has been given ample time to
do so. I therefore find that resolution of the pending motion, based on the authority vested
in me as recognized by the Federal Circuit, is appropriate at this time – and I need not be
guided by summary judgment fact-finding standards in so doing.
III. Analysis of Substantive Issues Raised by Respondent’s Motion
A. Adequacy of Table Claim
Pursuant to the Vaccine Injury Table, GBS is compensable if it manifests within 3-
42 days after the administration of a flu vaccine. 42 C.F.R. § 100.3(a)(XIV)(D) (2017).
Additional criteria can be found in the Qualification and Aids to Interpretation (“QAI”). 42
C.F.R. § 100.3(c)(15). Respondent argues that Petitioner’s case fails on several areas.
First, Respondent maintains that the onset of Petitioner’s symptoms does not fit
the Table period. Petitioner received the flu vaccine on September 24, 2012, while
hospitalized for esophageal surgery performed five days earlier (September 19, 2012).
Exhibit 5 at 39-40. The exact time of administration is not clearly noted in the vaccine
record, but it appears it may have been administered at approximately 10:01 am. Exhibit
1 at 9. Under the Table’s timeframe, onset would have to be no earlier than the morning
of September 27th.
On Saturday, September 29, 2012, Petitioner visited the emergency room,
complaining of lower extremity weakness and numbness. Exhibit 5 at 10. She initially
reported to treaters at this time that she had been experiencing these symptoms for three
days. Normally, this would place onset as occurring on September 26, 2012, or two days
5
after vaccination (and hence too short to meet the Table timeframe). However, Petitioner
also identifies onset as occurring on Thursday morning when she woke. Id. This would
place onset early on September 27, 2012 - close to but not quite three days after
vaccination. Later histories are less exact, but all place onset around approximately the
same time.
Given the above, the question of onset in this case remains a close call. Under
such circumstances, relevant and persuasive case law suggests deciding the issue in
Petitioner’s favor. Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1280 (Fed.
Cir. 2005). Were this the sole issue with the adequacy of the Table claim, I would likely
find this matter in Petitioner’s favor.
There is, however, a second and far more problematic issue: whether the illness
Petitioner suffered was GBS or some other condition. There is no clear GBS diagnosis in
the medical records filed by Petitioner, and her symptoms are often reported to be
atypical.5 In fact, on several instances, Petitioner’s treating physicians theorized that her
symptoms may be psychosomatic.6
When Petitioner first sought treatment on September 29, 2012, she visited her
primary care provider William L. Pridgen, M.D., before going to the hospital. Exhibit 4 at
23-24. She had seen Dr. Pridgen six days earlier on September 23, 2012, complaining of
nausea, vomiting, and the feeling of a tear when throwing up. Id. at 25. At that visit, Dr.
Pridgen indicated Petitioner was not taking her medicine and thus had likely experienced
a viral activation that needed to be suppressed with medication. Id.
When she returned to Dr. Pridgen’s office, complaining of weakness and
numbness in her lower extremities, Dr. Pridgen attributed her symptoms to the same viral
flare he had opined that she was experiencing, noting that according to Petitioner and her
family she had experienced “transient lower extremity paralysis . . . in the past . . . [when]
on suppression therapy, . . . certainly during non-treatment, which is the reason for the
suppression in the first place.” Exhibit 4 at 23. According to Dr. Pridgen, “that is exactly
5
For example, in the medical records from an emergency room consult on October 26, 2012, it is noted
that “[r]eview of her clinical course is somewhat atypical in that spinal fluid analysis was negative and the
patient had sensory involvement.” Exhibit 10 at 129.
6
In an October 3, 2012 note in the medical records from DCH Hospital, it is noted that some lower
performance “may be supratentorial.” Exhibit 5 at 31. Supratentorial means superior to the tentorium of the
cerebellum. DORLAND ’S ILLUSTRATED MEDICAL DICTIONARY (“DORLAND ’S”) at 1806. Thus, this entry appears
to be a complex way of saying in her head. A much clearer statement can be found in a DCH Hospital
medical records from October 31, 2012. The statement is as follows: “Neurology saw the patient. There
was some concern that some of the symptoms could be psychosomatic related.” Exhibit 10 at 117.
Psychosomatic means “pertaining to the mind-body relationship; having bodily symptoms of psychic,
emotional, or mental origin.” DORLAND’S at 1550.
6
what happened here.” Id. Petitioner had previously been diagnosed with Henoch-
Schonlein Purpura7 when 10 years old.
Later entries show other treating physicians similarly uncertain of a GBS diagnosis.
For example, in the medical records from an October 8, 2012 consultation, the treating
physician questioned whether the proper diagnosis was an inflammatory response such
as GBS vs. toxic neuropathy. Exhibit 5 at 36. Regarding a second bout of lower extremity
numbness suffered by Petitioner on October 26, 2012, there is a reference to a UTI
(urinary tract infection) and Petitioner acknowledges that she again was taking HSV
medication intermittently. Exhibit 10 at 118, 124.
The discussion in this section provides a few examples of the information
contained in the medical records casting significant doubt on whether Petitioner’s illness
satisfies the Table definition of GBS, or can even be properly characterized as GBS. But
a petitioner cannot prevail on a Table claim if she cannot satisfy the Table’s definition for
the injury. Here, the existing record preponderates against the conclusion that Petitioner
did in fact experience GBS. Moreover, Petitioner has been given ample opportunity to
supplement that record – here, with an expert report that could synthesize the record and
explain how GBS is the proper diagnosis despite a lack of treater record support.
Examining the whole record in this case, I find that Petitioner has not provided
preponderant evidence showing her illness meets the Table definition for GBS.
B. Untimeliness of Claim
In many cases, the fact that a claimant cannot meet a Table definition or
requirement does not constitute the end of the case, since the claimant might well be able
to establish a non-Table, causation-in-fact version of the claim not subject to those
requirements. Here, for example, Petitioner might be able to show that her injury
(whatever it is) is some kind of GBS-like neuropathy caused by the flu vaccine. (She
would, of course, then be obligated to meet the three elements of the test set forth in
Althen, 418 F.3d at1278).
But Petitioner’s ability to refashion her claim into a non-Table cause of action is not
possible under the circumstances, due to the late date the matter was filed. It is not
disputed that Petitioner received the flu vaccine on September 24, 2012. Accordingly, to
be timely filed under the Vaccine Act’s 36-month statute of limitations, Petitioner should
have filed her petition by no later than a date in September 2015 (based upon onset).
7
Henoch-Schonlein Purpura is a disorder causing inflammation and bleeding in the small blood vessels.
See https://www.webmd.com/skin-problems-and-treatments/henoch-schonlein-purpura-causes-
symptoms-treatment#1 (last visited on Oct. 27, 2020).
7
Section 16(a)(2). But this matter was initiated in March 2018 – approximately two and
one-half years later. It is thus facially untimely.
Petitioner argues the contrary, relying on the Act’s “lookback” provision (Section
16(b)). Opp. at 1. That provision is triggered by a Table revision, and allows petitioners to
file otherwise-untimely petitions within two years of the revision’s effective date, for
vaccine-related injuries suffered during the eight years prior to the revision. Section 16(b).
Thus, Petitioner maintains, because the Vaccine Table was revised in 20178 to include a
claim for GBS after receipt of the flu vaccine, the present claim (filed a year after the Table
change) is timely since it alleges a Table claim.
Petitioner’s reasoning is incorrect. I have previously determined that the “lookback”
provision of the Vaccine Act “does not save a non-Table version of a flu-GBS claim.”
Randolph v. Sec’y of Health & Human Servs., No. 18-1231V, 2020 WL 542735, at *8
(Fed. Cl. Spec. Mstr. Jan. 2, 2020) (emphasis added). Rather, once it is determined that
any particular claim cannot satisfy the Table requirements, the lookback provision no
longer applies. My determination is in line with prior decisions from other special masters.
Gorski v. Sec’y of Health & Human Servs., No. 97-156V, 1997 WL 739497, at *6 (Fed.
Cl. Spec. Mstr. Nov. 13, 1997).
Here, my conclusion that Petitioner cannot preponderantly meet the requirement
of a flu-GBS Table claim takes her out of the lookback’s safe harbor. Because Petitioner
filed her case well after the expiration of the Vaccine Act’s 36-month statute of limitation,
her petition is untimely filed, and thus must be dismissed.
C. Severity Requirement
In addition to the foregoing, dismissal is also warranted because Petitioner cannot
demonstrate that she suffered the residual effects of her illness for more than six months.
The last mention of lower extremity weakness and numbness can be found in the
medical records from treatment Petitioner received in late October 2012 for her second
bout of these symptoms. This was less than two months from onset. Thereafter, Petitioner
suffered from right hand parenthesis and weakness on May 23, 2013. Exhibit 10 at 58.
However, the medical record from that visit establishes that the treating physician clearly
opined that “[t]he patient’s examination is not consistent with Guillan barre [sic].” Id. at 63.
Petitioner visited the emergency room again on July 3, 2013, complaining of a migraine.
8
Effective for petitions filed beginning on March 21, 2017, GBS is an injury listed on the Table. See National
Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, Final Rule, 82 Fed. Reg.
6294 (Jan. 19, 2017); National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury
Table, Delay of Effective Date, 82 Fed. Reg. 11321 (Feb. 22, 2017) (delaying the effective date of the final
rule until March 21, 2017).
8
Id. at 20. Again, there is nothing in this medical record to link these symptoms to the
illness Petitioner suffered in October 2012. Id. at 20-44. Thus, the last symptom that
arguably could be linked to GBS occurred in late October/early November 2012, less than
two months after vaccination.
This record is insufficient to satisfy the Vaccine Act’s six-month statutory
requirement for severity. Section 16(c)(1)(D)(i). Not only can she not demonstrate that
she ever received a formal GBS diagnosis, but she cannot show that the symptoms that
arguably reflected GBS close-in-time to vaccination persisted or produced other sequelae
that lasted over time. Here, expert interpretation of the record would have potentially been
helpful – but despite the opportunity to provide it, Petitioner failed to file any such report.
This thus stands as another, independent basis for the claim’s dismissal.
IV. Conclusion
To date, and despite ample opportunity, Petitioner has failed to file preponderant
evidence to establish her Table claim, rendering the case untimely. She also cannot meet
the severity requirement applicable to all Program claims. Accordingly, this case is
DISMISSED for failure to prosecute. The clerk shall enter judgment accordingly.9
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
9
Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by the parties’ joint filing of notice
renouncing the right to seek review.
9