Romero v. Secretary of Health and Human Services

In the United States Court of Federal Claims

OFFICE OF SPECIAL MASTERS

No. 18-1625V

UNPUBLISHED

ROY ROMERO, Chief Special Master Corcoran

Petitioner, Filed: March 11, 2021

v.

Special Processing Unit (SPU);

SECRETARY OF HEALTH AND Findings of Fact; Onset; Influenza

HUMAN SERVICES, (Flu) Vaccine; Guillain-Barré

Syndrome (GBS)

Respondent.

Michael Adly Baseluos, Baseluos Law Firm, San Antonio, TX, for petitioner.

Camille Michelle Collett, U.S. Department of Justice, Washington, DC, for respondent.

FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CLAIM1

On October 19, 2018, Roy Romero 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 alleged that he suffered acute inflammatory demyelinating

polyneuropathy, a variant of Guillain-Barré Syndrome (“GBS”), as a result of an influenza

(“flu”) vaccine administered on October 21, 2016. Petition at 1. The case was assigned

to the Special Processing Unit (“SPU”) of the Office of Special Masters.

1 Because this unpublished fact ruling contains a reasoned explanation for the action in this case, I am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 fact ruling 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 “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa

(2012).

Although Mr. Romero did not formally allege a flu-GBS claim under the Vaccine

Injury Table (“Table”), this case was assigned to SPU based upon the initial assumption

that such a claim might be tenable. However, as discussed herein, the medical record

best supports the conclusion that the onset of Petitioner’s GBS occurred less than three

days after vaccination – and thus outside the prescribed 3-42 day Table onset period for

a flu-GBS injury. Because Petitioner cannot preponderantly establish all of the

requirements of a presumptive flu-GBS injury, his Table claim must be dismissed

(although the matter may proceed outside of SPU as a non-Table claim).

PROCEDURAL HISTORY

Petitioner initiated this case on October 19, 2018, alleging that he suffered GBS

as a result of a flu vaccine administered on October 21, 2016.3 Petition at 1. On January

27, 2020, Respondent filed a status report indicating that he intended to defend this case.

ECF No. 36.

Respondent filed a Rule 4(c) Report on May 14, 2020. In it, Respondent asserted

that Petitioner had not established that he suffered a presumptive flu-GBS injury as set

forth in the Table, or alternatively that Petitioner’s GBS was caused-in-fact by the

vaccination. Res. Report at 17-18. Regarding the Table requirements, Respondent

argued that Petitioner’s medical records variously placed the onset of his GBS the day of

vaccination, the day after vaccination, and/or two days after vaccination – all outside the

3-42 day Table onset period. Id. at 18. Respondent additionally contended that there was

evidence Petitioner’s GBS was caused by factors unrelated to the administration of the

vaccine (e.g., gastrointestinal illness). Id.

A status conference was held with the parties on July 1, 2020. During the

conference, the parties were informed that in light of the onset and alternative cause

issues raised by Respondent, Petitioner’s claim might not be viable, whether as a Table

or non-Table, causation-in-fact claim. ECF No. 42. The parties were directed to Rowan v.

Sec'y of Health & Human Servs., No. 17-760V, 2020 WL 2954954 (Fed. Cl. Spec. Mstr.

Apr. 28, 2020), a case in which I determined that a GBS onset sooner than three days

post-vaccination was not scientifically or medically supported, given that GBS is known

to be mediated by autoantibodies produced via the adaptive immune system, and this

process takes longer than three days to result in symptoms.

3 Petitioner also filed a Supplemental Petition on April 5, 2019, which incorporated and discussed medical

records that were filed after the original Petition. In the Supplemental Petition, Mr. Romero also asserted

that his pre-vaccination medical conditions were unrelated to the onset of his GBS. See generally

Supplemental Petition (ECF No. 13).

2

At a follow-up status conference held on July 13, 2020, Petitioner’s counsel stated

that he had consulted with an expert who believed Petitioner’s pre-vaccination

pancreatitis could in fact have caused an onset sooner than three days due to immune

system general activity. ECF No. 43. Counsel also maintained that Rowan could be

distinguished, primarily due to the fact that the petitioner in that case was elderly (and

therefore the immune process was likely to be slower). Id. And counsel further proposed

that it was possible the symptoms Petitioner experienced within three days of his

vaccination (e.g., weakness) were unrelated to GBS. Id.

In response, I reiterated my initial view that the Table claim did not appear viable

given the record evidence suggesting an onset of sooner than three days, although I

allowed that Petitioner might succeed with a non-Table causation-in-fact claim supported

by the proposed expert opinion. Id. I therefore expressed the intention to transfer this

case from SPU, given the time elapsed since the case was filed, the complexity of the

medical issues involved, and the unlikelihood of informal resolution. Id.

I also indicated my expectation that the Table version of the claim warranted

dismissal – although I noted that I would permit Petitioner to show cause why this should

not occur. Id. I emphasized, however, that Petitioner should not obtain an expert report

(although he could attempt to explain why the record facts supported a Table claim, and

how an expert opinion would assist that showing). Id. After briefing, I noted that I would

rule on the Table claim, and then (assuming I acted as predicted) transfer the matter for

adjudication of the causation-in-fact claim. Id.

Petitioner filed a brief (“Br.”) regarding his Table claim on September 28, 20204

(ECF No. 47), and Respondent opposed the Table claim’s maintenance (“Opp.”) on

October 20, 2020. ECF No. 48. Petitioner filed a reply brief on October 21, 2020. ECF

No. 49. Accordingly, this case is now ripe for a determination.

AUTHORITY

Before compensation can be awarded under the Vaccine Act, a petitioner must

demonstrate, by a preponderance of evidence, all matters required under Section

11(c)(1), including the factual circumstances surrounding his claim. Section 13(a)(1)(A).

In making this determination, the special master or court should consider the record as a

whole. Section 13(a)(1). Petitioner’s allegations must be supported by medical records or

by medical opinion. Id.

4 Petitioner also filed an affidavit on September 27, 2020 providing a timeline of his post-vaccination

symptoms. ECF No. 46.

3

To resolve factual issues, the special master must weigh the evidence presented,

which may include contemporaneous medical records and testimony. See Burns v. Sec'y

of Health & Human Servs., 3 F.3d 415, 417 (Fed. Cir. 1993) (explaining that a special

master must decide what weight to give evidence including oral testimony and

contemporaneous medical records). Contemporaneous medical records are presumed to

be accurate. See Cucuras v. Sec’y of Health & Human Servs., 993 F.2d 1525, 1528 (Fed.

Cir. 1993). To overcome the presumptive accuracy of medical records testimony, a

petitioner may present testimony which is “consistent, clear, cogent, and compelling.”

Sanchez v. Sec'y of Health & Human Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed.

Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Human Servs., No.

90–2808V, 1998 WL 408611, at *5 (Fed. Cl. Spec. Mstr. June 30, 1998)).

In addition to requirements concerning the vaccination received, the duration and

severity of petitioner’s injury, and the lack of other award or settlement,5 a petitioner must

establish that he suffered an injury meeting the Table criteria, in which case causation is

presumed, or an injury shown to be caused-in-fact by the vaccination he received.

Section 11(c)(1)(C).

The most recent version of the Table, which can be found at 42 C.F.R. § 100.3,

identifies the vaccines covered under the Program, the corresponding injuries, and the

time period in which the particular injuries must occur after vaccination. Section 14(a).

Pursuant to the Vaccine Injury Table, GBS is compensable if it manifests within 3-42 days

(not less than three days and not more than 42 days) of the administration of a flu

vaccination. 42 C.F.R. § 100.3(a)(XIV)(D). Further criteria for establishing a GBS Table

injury can be found under the accompanying Qualifications and Aids to Interpretation. 42

C.F.R. § 100.3(c)(15).

Cases alleging a flu-GBS Table injury have often been dismissed for failure to

establish proper onset. See, e.g., Randolph v. Sec'y of Health & Human Servs., No. 18-

1231V, 2020 WL 542735, at *8 (Fed. Cl. Spec. Mstr. Jan. 2, 2020) (finding GBS onset at

the earliest occurred 76 days post-vaccination, “well outside the 3-42 day window set by

the Table for a flu-GBS claim”); Upton v. Sec'y of Health & Human Servs., No. 18-1783V,

2020 WL 6146058, at *2-3 (Fed. Cl. Spec. Mstr. Sept. 24, 2020) (finding the petitioner did

not establish the onset of his GBS within the 3-42 day time frame prescribed and thus did

not establish a Table Injury).

5In summary, a petitioner must establish that he received a vaccine covered by the Program, administered

either in the United States and its territories or in another geographical area but qualifying for a limited

exception; suffered the residual effects of his injury for more than six months, died from his injury, or

underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected

an award or settlement for his injury. See § 11(c)(1)(A)(B)(D)(E).

4

ANALYSIS

After reviewing the entire record, including all medical records, affidavits,

Respondent’s Rule 4(c) Report,6 and the parties’ briefing, I have concluded that the onset

of Petitioner’s GBS occurred less than three days after vaccination and thus outside the

prescribed flu-GBS Table onset period.7 I have specifically based my finding on the

following evidence:

• On October 21, 2016, Petitioner presented to David Gomez, PA-C, at Ramos

Family Medical Group to establish care as a new patient. Ex. 17 at 3-5. During the

appointment, Petitioner was administered a flu vaccine. Id. at 4.

• Five days later, on October 26, 2016, Petitioner presented to the emergency room

at University Health System. Ex. 11 at 212. An intake record noted that Petitioner

was recently hospitalized due to pancreatitis8 and had been prescribed medication

for diabetes, high cholesterol, hypertension, and GERD. Id. Petitioner indicated

that, since taking the aforementioned medications, he had experienced

progressive weakness with difficulty performing fine motor tasks and decreased

energy. Id.

• Shortly thereafter on that same date, Petitioner was assessed by an emergency

room physician, who noted that Petitioner had experienced numbness of his hands

for five days, but that two-to-three days ago had also begun experiencing bilateral

lower extremity weakness and pain. Id. at 210.

• A second emergency room physician recorded on October 26, 2016, that Petitioner

was in his normal state of health four days prior, but reported numbness and

weakness of the extremities for three days. Id. at 205. Petitioner was further noted

to have fatigue and tingling in the bilateral lower extremities leading to weakness

6 In his Report, Respondent identified several records that are potentially outstanding – including records

associated with a medical appointment on October 25, 2016. See, e.g., Res. Report at 6 n.7. Petitioner has

asserted that many of the records requested by Respondent do not exist and that all relevant medical

records have been filed. See, e.g., Res. Report at 6; Petitioner’s Amended Statement of Completion, filed

December 19, 2019 (ECF No. 34). I find that the available record is sufficient to make a limited finding

regarding the nonviability of Petitioner’s flu-GBS Table claim.

7 A more complete recitation of the facts can be found in the Petition, Respondent’s Rule 4(c) Report, and

the parties’ briefing. Given the issues involved in this ruling, I have limited my discussion to the records

most relevant to the onset of Petitioner’s GBS.

8Petitioner was hospitalized from October 9 to October 11, 2016 for treatment of acute pancreatitis. See

Ex. 15 at 3-4, 13-14.

5

and an inability to walk. Id. The assessment was “[l]ikely Guillain Barre vs. atypical

ALS.” Id. at 207.

• A third emergency room physician recorded on October 26, 2016 that Petitioner

began experiencing bilateral lower extremity weakness for two-to-three days that

had progressed upward toward his upper extremities. Ex. 11 at 208. Petitioner was

referred for a neurology consultation. Id. at 209.

• Petitioner underwent a resident neurology consultation on October 26, 2016, at

University Health System. Id. at 199. Petitioner stated that he had received a flu

vaccination on Friday (October 21) and had begun experiencing weakness of the

hands on Sunday (October 23). Id. By Monday (October 24) he began walking

slowly, and he was unable to walk by Tuesday. Id. A “Faculty Attestation” from the

attending neurologist noted that Petitioner had a flu vaccination a “few days ago

and the next day noticed weakness and the following day unable to walk.” Id. at

203.

• Petitioner underwent an EMG/NCS study on October 31, 2016. Id. at 152. The

medical history provided indicated that Petitioner had weakness of the arms and

legs since “~8 days ago” (or October 23rd). Id. Petitioner also stated that he

received a flu vaccination two days prior to the onset of symptoms. Id.

• On November 1, 2016, Petitioner had a rehabilitation consultation for treatment of

upper and lower extremity weakness. Id. at 139. Petitioner reported that he had

received a flu vaccine about three days prior to the onset of his symptoms. Id.

• On November 11, 2016, Petitioner had an internal medicine consultation for

treatment of a fever. Ex. 3 at 184-88. Petitioner reported that he had been

administered a flu vaccine two days prior to the start of his weakness. Id. at 185.

• On September 27, 2020, Petitioner filed an affidavit providing a timeline of his

symptom onset following the October 21, 2016 vaccination.9 Ex. 21. Petitioner

averred that he noticed weakness in his hands at 10 PM on October 23, 2016. Id.

at 1. Petitioner further stated that he began experiencing difficulty using his hands

and walking over the following two days. Id. at 1-2.

The records above provide varying dates regarding the onset of Petitioner’s GBS.

Nevertheless, I find that the cumulative record evidence preponderantly supports an

9Petitioner previously filed a timeline of his symptom onset in conjunction with his Petition (Ex. 4), which is

consistent with the September 27, 2020 timeline.

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onset of less than three days after vaccination. In making this determination, I find the

records associated with Petitioner’s October 26, 2016 neurological consultation to be

especially probative. These records specifically include a day-by-day description of

Petitioner’s early symptoms. Indeed, the examining neurologist recorded that Petitioner

received a flu vaccination on Friday, October 21, 2016, and began experiencing

weakness of the hands on Sunday, October 23, 2016. Ex. 11 at 199. Petitioner was further

noted to have begun walking slowly on Monday, October 24, 2016 with a complete

inability to walk the following day. Id. In addition to being detailed and contemporaneous

with the events described therein, these records comport with Petitioner’s affidavit and

the timeline he provided regarding his symptom onset.

There are other onset concessions made by Petitioner in this case. In his brief,

Petitioner notes that after speaking to his expert, “it appears the weakness in [his] hands

54-55 hours of vaccination may represent the first objective sign of GBS/AIDP alleged to

be caused by vaccination.” Br. at 2. Petitioner further acknowledges that his post-

vaccination symptoms do not appear to comport with the timeline prescribed in the Table.

Id. Even so, Petitioner states that he does not concede that he cannot establish a flu-GBS

Table claim because further expert input, or other evidence, might show that his initial

symptoms were unrelated to the onset of GBS. Id. at 2-3. Petitioner therefore requests

that I transfer this matter out of SPU without dismissing the flu-GBS Table claim. Id. at 3.

I have considered Petitioner’s arguments but do not find them persuasive. Initially,

as described, both Petitioner and his expert appear to admit that Petitioner’s GBS

symptoms began less than three days after vaccination. I further note that Petitioner’s

initial post-vaccination symptoms, including weakness, are consistent with GBS based on

the Table’s Qualifications and Aids to Interpretation and my prior experience adjudicating

Program cases. See 42 C.F.R. § 100.3(c)(15)(ii) (listing weakness as a requirement for

the diagnosis of acute inflammatory demyelinating polyneuropathy). I therefore conclude

that further factual development and expert input are not needed to determine that the

onset of Petitioner’s GBS occurred less than three days after vaccination – outside the 3-

42 day Table onset period. Accordingly, Petitioner’s Table Claim for flu-GBS is

dismissed. Because the matter no longer includes a Table claim (and otherwise cannot

be decided, as discussed below, in an expedited timeframe), it is appropriate to transfer

it out of SPU.

In his brief, Respondent questions the viability of Petitioner’s remaining non-Table

causation-in-fact claim, asserting that there may not be a reasonable basis for Petitioner

to retain an expert in furtherance of it. Opp. at 2-4. Respondent specifically references

the issues regarding the early onset of Petitioner’s GBS, and also notes that Petitioner

had a pre-vaccination history of gastrointestinal illness – a possible alternative cause.

7

See 42 U.S.C. § 300aa-13(a)(1)(B) (noting that compensation shall not be awarded if a

preponderance of the evidence indicates the illness, disability, injury, condition, or death

described in the petition is due to factors unrelated to the administration of the vaccine

described in the petition).

I have considered Respondent’s arguments. Although Respondent raises issues

that may ultimately prevent an entitlement finding in Petitioner’s favor, the present record

is insufficiently developed to resolve a non-Table version of this claim. Petitioner could

establish, for example, through expert testimony or other persuasive evidence, that the

specific circumstances of this case explain an earlier-than-usual onset, despite what is

known about GBS’s pathogenesis. He may also be able to rebut arguments regarding

alternative cause. For these reasons, dismissal of the entire case would be premature.

Rather, Petitioner should be permitted to proceed with his remaining non-Table

causation-in-fact claim after this case is transferred out of SPU.

CONCLUSION

• For the reasons described above, Petitioner’s flu-GBS Table Claim is dismissed.

• Pursuant to Vaccine Rule 3(d), I will issue a separate order reassigning this case

randomly to a Special Master.

IT IS SO ORDERED.

s/Brian H. Corcoran

Brian H. Corcoran

Chief Special Master

8