Orion v. Secretary of Health and Human Services

In the United States Court of Federal Claims
OFFICE OF SPECIAL MASTERS
No. 20-806V
UNPUBLISHED
RONALD ORION, Chief Special Master Corcoran
Petitioner, Filed: January 11, 2022
v.
Special Processing Unit (SPU);
SECRETARY OF HEALTH AND Findings of Fact; Onset;Tetanus
HUMAN SERVICES, Diphtheria acellular Pertussis (Tdap)
Vaccine; Shoulder Injury Related to
Respondent. Vaccine Administration (SIRVA);
Brachial Neuritis
David John Carney, Green & Schafle, LLC, Philadelphia, PA, for Petitioner.
Claudia Barnes Gangi, U.S. Department of Justice, Washington, DC, for Respondent.
FINDINGS OF FACT AND CONCLUSIONS OF LAW DISMISSING TABLE CASE 1
On July 1, 2020, Ronald Orion 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 a Tdap vaccine Petitioner received on September 6, 2017,
caused him to suffer the Table injury of Parsonage-Turner Syndrome (also known as
brachial neuritis); alternatively that his brachial neuritis was caused-in-fact by his
vaccination; or that he suffered a different Table Injury, shoulder injury related to vaccine
1
Because this unpublished f act ruling contains a reasoned explanation f or the action in this case, I am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 section ref erences to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. §
300aa (2012).
administration (“SIRVA”). Amended Petition filed October 22, 2020. The case was
assigned to the Special Processing Unit of the Office of Special Masters (the “SPU”).
I. Relevant Procedural History – Order to Show Cause
On November 19, 2020, Respondent filed his counsel’s informal assessment of
this case, pursuant to my Order, identifying a legal issue regarding the onset of
Petitioner’s alleged brachial neuritis. ECF No. 14 at 2. On July 14, 2021, I issued an Order
to Show Cause, as it appeared based upon my review that Petitioner would neither be
able to establish any form of Table claim - brachial neuritis or SIRVA. ECF No. 18. I
therefore advised Petitioner that I would likely reassign this case from SPU, since all that
remains to be litigated is some form of causation-in-fact claim that is not appropriate for
resolution in SPU. ECF No. 18 at 2. I further advised that if I determined that Petitioner’s
Table claims must be dismissed, I would issue Findings of Fact and Conclusion of Law
Dismissing Petitioner’s Table Claims, and transfer the matter out of SPU. Id. at 3.
On August 17, 2021, Petitioner filed a Status Report in response to my Order to
Show Cause, indicating that he “will consent to the Table claims of SIRVA and brachial
neuritis being dismissed while preserving Petitioner’s right to proceed under a causation-
in-fact claim for either SIRVA and/or brachial neuritis after receipt of vaccination.” ECF
No. 19.
On September 14, 2018, Respondent filed a response to Petitioner’s Show Cause
Filing/Status Report, representing that he “does not object to (1) the transfer of this case
out of the SPU, (2) the dismissal of the Table claims of SIRVA and brachial neuritis, or
(3) [P]etitioner’s request to preserve his right to proceed under a theory of causation-in-
fact for his alleged brachial neuritis.” ECF No. 20 at 1 (emphasis in original). Respondent,
however, argues that “because ‘SIRVA’ is an injury defined by administrative rulemaking,
. . . [P]etitioner may not pursue a cause-in-fact SIRVA claim.” Id. Rather, Respondent
asserts, Petitioner may only pursue a cause-in-fact claim to a specific shoulder injury if
one can be established. Id. at 1-2.
II. Analysis and Findings of Fact
To establish a Table claim for brachial neuritis, onset of the injury must occur not
less than two days, or more than 28 days, following vaccination. 42 C.F.R. §
100.3(a)(I)(B). However, in this case the record supports the conclusion that onset of
Petitioner’s symptoms occurred six hours 3 after his receipt of the Tdap vaccine - thus
3
Petitioner was seen at the emergency room of Orange Regional Medical Center on September 8, 2017,
and reported the onset of his shoulder pain as follows:
2
precluding a Table claim for brachial neuritis. Ex. 1 at 66; see also ECF No. 14 at 2
(Respondent’s informal assessment raising this issue), ECF No. 18 (my Order to Show
Cause discussing this issue and directing Petitioner to Show Cause why his brachial
neuritis Table claim should not therefore be dismissed). Petitioner has offered no
evidence or argument to the contrary, and has consented to the dismissal of this aspect
of his overall case. ECF No. 19.
In regard to Petitioner’s alternative claim of a Table SIRVA, Petitioner has likewise
failed to establish the QAI requirements for a SIRVA Table case, 4 given his treaters’
assessments of “radicular pain in left arm” (Ex. 1 at 69) and “Parsonage-Turner
syndrome” (Ex. 3 at 25), as well as Petitioner’s pre-vaccination history of a left shoulder
arthroplasty in January 2015 to treat osteoarthritis (ECF No. 13 at ¶2). See also ECF No.
On 9/6/17, the patient was in the ED for right eye pain and received a tetanus shot. Six
hours later, he states that pain to the left arm began starting in the shoulder and radiating
to the hand. Aleve and ibuprofen taken at home have been ineffective for pain relief.
Hardware in the lef t arm s/p previous shoulder surgery noted. Due to persistent pain, he
has come to the ED for further evaluation.
Ex. 1 at 66. The impression was radicular left arm pain. Id. at 69. On November 22, 2017, a diagnosis of
Parsonage-Turner Syndrome was confirmed. Ex. 3 at 25.
4
In pertinent part, the QAI for the Table Injury of SIRVA states:
Shoulder Injury Related to Vaccine Administration (SIRVA). SIRVA manifests as shoulder
pain and limited range of motion occurring after the administration of a vaccine intended
f or intramuscular administration in the upper arm. These symptoms are thought to occur
as a result of unintended injection of vaccine antigen or trauma from the needle into and
around the underlying bursa of the shoulder resulting in an inflammatory reaction. SIRVA
is caused by an injury to the musculoskeletal structures of the shoulder (e.g. tendons,
ligaments, bursae, etc). SIRVA is not a neurological injury and abnormalities on
neurological examination or nerve conduction studies (NCS) and/or
electromyographic (EMG) studies would not support SIRVA as a diagnosis (even if
the condition causing the neurological abnormality is not known). A vaccine
recipient shall be considered to have suffered SIRVA if such recipient manifests all of the
f ollowing:
(i) No history of pain, inflammation or dysfunction of the affected shoulder prior to
intramuscular vaccine administration that would explain the alleged signs,
symptoms, examination findings, and/or diagnostic studies occurring after vaccine
injection;
(ii) Pain occurs within the specified time frame;
(iii) Pain and reduced range of motion are limited to the shoulder in which the
intramuscular vaccine was administered; and
(iv) No other condition or abnormality is present that would explain the patient’s
symptoms (e.g. NCS/EMG or clinical evidence of radiculopathy, brachial neuritis,
mononeuropathies, or any other neuropathy).
42 C.F.R. § 100.3(c)(10)(emphasis added).
3
18 at 2-3 (my Order to Show discussing these issues and directing Petitioner to Show
Cause why his Table SIRVA claim should not be dismissed). Again, Petitioner has offered
no additional evidence or argument to the contrary, and has consented to the dismissal
of his Table SIRVA claim. ECF No. 19.
Accordingly, for the above stated reasons I find 5 that Petitioner has failed to
demonstrate the Table requirements for brachial neuritis (42 C.F.R. § 100.3(a)(I)(B))
and SIRVA (42 C.F.R. § 100.3(c)(10)), and hereby dismiss Petitioner’s Table brachial
neuritis and SIRVA claims.
III. Scheduling Order
In light of the instant ruling, I will proceed with transferring Petitioner’s case out of
SPU and will randomly reassign the case to a special master to conduct further
proceedings to establish whether Petitioner has demonstrated an off-Table case for some
kind of injury. 6
On October 18, 2021, Petitioner filed a Status Report indicating that he was waiting
to receive a set of records requested by Respondent from Hospital of Special Surgery
and would file these records upon receipt. ECF No. 22. These records have not yet been
filed. Accordingly, Petitioner shall file his outstanding records from Hospital of
Special Surgery, by no later than February 10, 2022.
IT IS SO ORDERED.
s/Brian H. Corcoran
Brian H. Corcoran
Chief Special Master
5
I make these f indings after a complete review of the record, including all medical records, affidavits, and
all other additional evidence and filings from the parties.
6
I reject Respondent’s assertion that a petitioner could never pursue an off-Table case of SIRVA, since it
is envisionable that expert support could in a proper case help establish a comparable injury even if the
literal Table requirements are not met (just as claimants can prove the flu vaccine caused GBS in a non-
Table context). But I decline to make any preliminary f indings in regard to whether the Petitioner in this
case can establish entitlement to any off-Table injury.
4