Byndloss v. Secretary of Health and Human Services

United States Court of Federal Claims·Decided July 2, 2024·No. 20-0781V·Unpublished

Opinion

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 20-0781V

RENEE BYNDLOSS, Chief Special Master Corcoran

Petitioner,

v. Filed: May 16, 2024

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent.

Edward M. Kraus, Kraus Law Group, LLC, Chicago, IL, for Petitioner.

Ryan Nelson, U.S. Department of Justice, Washington, DC, for Respondent.

FINDINGS OF FACT, CONCLUSIONS OF LAW, AND TRANSFER ORDER – SPECIAL PROCESSING UNIT1

On June 26, 2020, Renee Byndloss filed a Petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §300aa-10, et seq.2 (the “Vaccine Act”). ECF No. 1. Petitioner alleges that she received tetanus-diphtheriaacellular pertussis (“Tdap”) vaccine and measles-mumps-rubella (“MMR”) vaccines on May 7, 2018, bilaterally, and further alleges that these vaccines caused her to suffer either two concurrent shoulder injuries related to vaccine administration (“SIRVA”), or a SIRVA from the Tdap vaccine and a causation-in-fact injury from the MMR vaccine.

1 Because this Ruling contains a reasoned explanation for the action taken in this case, it must be made

publicly accessible and will be posted on the United States Court of Federal Claims' website, and/or at https://www.govinfo.gov/app/collection/uscourts/national/cofc, in accordance with the E-Government Act of 2002. 44 U.S.C. § 3501 note (2018) (Federal Management and Promotion of Electronic Government Services). This means the 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 references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012).

Based on the record and the parties’ filings, I find preponderant evidence supports the conclusion that both vaccines were likely administered in Petitioner’s left arm, with the MMR vaccine administered subcutaneously.

I. Procedural History

Well after the case’s filing and activation, Respondent filed his Rule 4(c) Report in which he opposed compensation. Rule 4(c) Report (ECF No. 29). On December 2, 2021, I ordered any additional evidence (from Petitioner) and sequential briefing on facts that were disputed between the parties. Scheduling Order (ECF No. 30). Petitioner completed her filings on January 31, 2022. See Exs. 14 – 16 (ECF No. 32); Memorandum in Support of her Claim of Bilateral Shoulder Injuries (ECF No. 34) (“Brief”). On April 12, 2022, Respondent filed a Response (ECF No. 36). The matter is ripe for adjudication.

II. 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.

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 & Hum. 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 & Hum. 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 & Hum. Servs., No. 11–685V, 2013 WL 1880825, at *3 (Fed. Cl. Spec. Mstr. Apr. 10, 2013) (citing Blutstein v. Sec'y of Health & Hum. 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,3 a petitioner must

3 In 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

establish that she 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 she 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, a SIRVA is compensable if it manifests within 48 hours of the administration of a flu vaccine. 42 C.F. R. § 100.3(a)(XIV)(B). The criteria establishing a SIRVA under the accompanying QAI are as follows:

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 for 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 following:

(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

underwent a surgical intervention during an inpatient hospitalization; and has not filed a civil suit or collected an award or settlement for her injury. See Section 11(c)(1)(A)(B)(D)(E).

(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) (2017).

III. Evidence

I have reviewed all submitted evidence, including the medical records and affidavits, Petition, the Rule 4(c) Report, and both parties’ briefs. The following section focuses on the evidence most relevant to the issues to be resolved.

A. Medical Records

Petitioner was born in 1968. She last saw primary care physician Natalie Karishev, M.D., in September 2014. Ex. 6 at 1; see also Ex. 13 at 11. On April 3, 2018, she established care with Dennis Townsend, M.D., at the Milvia Family Medicine clinic. Ex. 3 at 40.4 No musculoskeletal complaints or findings were noted. Id. at 40 – 42.

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