McFadden v. Secretary of Health and Human Services

CourtUnited States Court of Federal Claims
DecidedFebruary 8, 2021
Docket16-1192
StatusUnpublished

This text of McFadden v. Secretary of Health and Human Services (McFadden v. Secretary of Health and Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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McFadden v. Secretary of Health and Human Services, (uscfc 2021).

Opinion

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-1192V Filed: January 11, 2020

* * * * * * * * * * * * * * * MEGAN C. MCFADDEN, * To Be Published * Petitioner, * v. * Finding of Facts; Onset; Influenza (“Flu”) * Vaccine; Shoulder Injury Related to SECRETARY OF HEALTH * Vaccine Administration (“SIRVA”) AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * *

Alexander Laufer, Esq., Eisenhower and Laufer, PC, Fairfax, VA, for petitioner. Mark Hellie, Esq., U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ONSET1 Roth, Special Master: On September 23, 2016, Megan McFadden (“petitioner” or “Ms. McFadden”) filed a petition pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. § 300aa-10 et seq.2 (“Vaccine Act” or “the Program”). Petitioner alleged that as a result of a quadrivalent influenza (“flu”) vaccination she received on September 28, 2013 she developed a shoulder injury related to vaccine administration (“SIRVA”). Petition at 1, ECF No. 1. For the detailed reasons set forth below, I find that petitioner developed a shoulder injury related to the receipt of a flu vaccine within 24 hours of receiving her September 28, 2013 flu vaccine.

1 This Ruling has been designated “to be published,” which means I am directing it to be posted on the Court of Federal Claims website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). This means the Ruling will be available to anyone with access to the internet. However, the parties may object to the Ruling’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each par ty has fourteen days within which to 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, the whole Ruling will be available to the public. Id. 2National 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). I. PROCEDURAL HISTORY

The petition was filed on September 23, 2016, along with petitioner’s af fidavit and medical records. See Petition, Petitioner’s Exhibits (“Pet. Ex.”) 1-5, ECF No. 1. This case was initially assigned to the Special Processing Unit (“SPU”). ECF No. 4. Petitioner filed additional medical records on October 4, 2016. Pet. Ex. 6-8, ECF No. 6.

Following the initial status conference on November 9, 2016, petitioner was ordered to file her primary care records for three years prior to vaccination. Scheduling Order, ECF No. 8. Petitioner filed the additional medical records on January 9, 2017. Pet. Ex. 9-10, ECF No. 10.

Respondent filed his Rule 4(c) Report (“Resp. Rpt.”) on April 10, 2017, recommending against compensation in this matter. ECF No. 15. It was respondent’s position that petitioner’s claim did not satisfy the criteria for an on-Table SIRVA injury. Resp. Rpt. at 6 n.7. Specifically, respondent pointed out that the contemporaneous medical records did not “document complaints of shoulder pain until a visit on March 7, 2014, nearly six months after vaccination, at which time [petitioner] stated that her pain began around November 2013 and was due to picking up her child.” Id. at 7. Respondent noted that the history given by petitioner placed the onset of her shoulder pain “approximately two months after her vaccination.” Id. Respondent further noted that petitioner “sought medical treatment six times between the date of her vaccination and the March 2014 visit, and there is no mention of left shoulder pain in the records of any of those visits.” Id. Additionally, petitioner reported in March 2014 that her pain “was associated with lifting her child” and placed onset one month after vaccination. Id. Respondent pointed out that petitioner did not associate her shoulder pain with a vaccination until April 4, 2014, during a phone call to Fort Belvoir; she did not mention her alleged vaccine-related shoulder pain to any of her treating doctors in Okinawa, Japan. Id.

Respondent also noted that petitioner was inconsistent in reporting the timing of onset. Resp. Rpt. at 8. Petitioner initially reported to Fort Belvoir that her shoulder pain started five days post-vaccination, but “when she saw Dr. Montgomery on April 30, 2014,” she reported “that her left shoulder pain began ‘within 24 hrs.’ of her vaccination and that her pain reached a ‘peak’ five days later.” Id. Additionally, respondent requested that petitioner provide “addition[al] evidence documenting the administration of the flu vaccine that is the subject of her claim.” Id. Respondent noted that petitioner reported a different vaccination date to Fort Belvoir, and that there was no office visit documenting administration of the allegedly causal vaccine. Id. at 8-9.

Following the filing of respondent’s Rule 4(c) Report, an Order was issued for petitioner to file additional evidence documenting vaccine administration as well as a detailed affidavit addressing the factual issues raised by respondent, including the onset of her symptoms and her lack of complaints of shoulder pain between October 2013 and March 2014. Scheduling Order at 1-2, ECF No. 16.

During a status conference on July 14, 2017, petitioner’s counsel advised that he was in the process of obtaining additional medical records from the military. Scheduling Order at 1, ECF No. 19. Respondent requested that petitioner also file records of any medical care she received while in Hawaii and Seattle. Id. Petitioner filed a status report (“Pet. S.R.”) on August 7, 2017,

2 advising that she was still in the process of obtaining her medical records from the military; petitioner also advised that she had not received any treatment for her alleged shoulder injury in Seattle or Hawaii. Pet. S.R. at 1, ECF No. 20. Petitioner later filed a Motion to Issue Subpoena to obtain her medical records from the military; this motion was granted. See ECF Nos. 26-27. The medical records were ultimately filed on December 30, 2017. Pet. Ex. 17, ECF No. 31. After reviewing the medical records, respondent filed a status report (“Resp. S.R.”) on January 30, 2018, advising that he was not open to settlement negotiations. Resp. S.R. at 1, ECF No. 35.

This matter was reassigned to me on February 5, 2018. ECF Nos. 36-37.

On February 20, 2018, petitioner filed an “opinion letter” from one of her treating physicians, Dr. Montgomery. Pet. Ex. 18, ECF No. 38. His letter provided a summary of the medical record from petitioner’s appointment on April 30, 2014, discussion of petitioner’s MRI taken on May 2, 2014, and his reasoning for why he diagnosed petitioner with SIRVA. See Pet. Ex. 18 at 1-2. Dr. Montgomery wrote “based upon other etiologies having been ruled out through interview, physical and radiographic examination, the reported vaccination technique, the chronology and character of her symptoms, and her demographics, it was my opin ion that Ms. McFadden’s condition was most consistent with “Shoulder Injury Related to Vaccine Administration” (SIRVA).” Id. at 2.

A status conference was held on March 28, 2018; petitioner’s counsel requested a fact hearing to resolve the issues raised by respondent.

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