Thomas v. Secretary of Health and Human Services

United States Court of Federal Claims·Decided July 10, 2019·No. 16-733·Unpublished

Opinion

In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 16-733V Filed: June 6, 2018

* * * * * * * * * * * * * * * LORA THOMAS, * * Petitioner, * v. * Ruling on Onset; Influenza (“Flu”) * Vaccine; Shoulder Injury Related to SECRETARY OF HEALTH * Vaccine Administration (“SIRVA”) AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * *

Edward M. Kraus, Esq., Law Offices of Chicago Kent, Chicago, IL, for petitioner. Ann D. Martin, Esq., U.S. Department of Justice, Washington, DC, for respondent.

RULING ON ONSET1

Roth, Special Master:

On June 22, 2016, Lora Thomas (“Ms. Thomas” or “petitioner”) 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 alleges that the seasonal influenza vaccine she received on September 13, 2013, caused her to suffer from pain, limited range of motion, and weakness in her right shoulder and upper arm. Petition, ECF No. 1.

Respondent stated that the medical records in this matter are insufficient to demonstrate the requisite facts to establish compensation under a causation theory and the most

1 This ruling will be posted on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). As provided in 42 U.S.C § 300aa- 12(d)(4)(B), however, the parties may object to the ruling’s inclusion of certain kinds of confidential information. To do so, each party may, within 14 days, 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, this decision will be available to the public in its present form. Id. 2 National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3755 (1986). Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42 U.S.C. § 300aa (2012). contemporaneous medical records are inconsistent with a claim of Shoulder Injury Related to Vaccine Administration (“SIRVA”). Respondent’s Rule 4(c) Report (“Resp. Report”) at 7, ECF No. 11. Respondent further stated that the record indicates that petitioner received both a flu vaccine and a shingles vaccine3 on September 13, 2013, but does not indicate in which arm each vaccine was administered; therefore, there is no proof that petitioner received the flu vaccine in her right arm. Id. at 7-8. Finally, respondent stated that the medical records show that petitioner did not mention any pain or other symptoms in her right arm or shoulder during medical appointments on October 24, 2013 and November 6, 2013. Id. at 8. The first complaint of a shoulder issue was relayed to a physician on January 10, 2014 in the context of multiple joint pains, including neck, shoulder, and heel pain. Id. The record of that visit does not contain any report that the onset of shoulder pain occurred in relation to petitioner’s September 2013 vaccinations. Id.

Petitioner filed an affidavit on June 27, 2016, affirming that she received a flu shot in her right arm at Walgreens on September 13, 2013. Pet. Ex. 11 at 1, ECF No.7. Petitioner stated that the pharmacist stood over her when she injected the vaccine; petitioner then felt some unusual pain and discomfort immediately after the vaccination. Id. Petitioner affirmed that, over the next few months, she had pain and weakness in her right shoulder but was also having significant ongoing problems with her back in the fall of 2013, which were more of a concern to her at that time because they affected her mobility and balance. Id. Petitioner was also preoccupied with taking care of her ill brother. Id. at 2. According to petitioner, her first complaint of shoulder pain was at a medical visit in January 2014 and then to her primary care physician in March 2014. Id.

In order to resolve the discrepancies between the medical records and the foregoing facts as submitted by petitioner, a fact hearing was held on June 8, 2017. The petitioner, Ms. Lora Thomas, her sister, Ms. Rita Thomas, and petitioner’s primary care physician, Dr. Raymond Kazmar, testified.

I. Procedural History

Petitioner filed her petition on June 22, 2016, and filed medical records and medical literature the following week. ECF Nos. 1, 6-7. Respondent filed a Rule 4(c) Report on October 5, 2016, stating that, based on the existing record, “petitioner has not demonstrated an entitlement to compensation under the terms of the Vaccine Act.” Resp. Rpt. at 9, ECF No. 11. From November 2016 through May 2017, petitioner filed additional medical records, articles of medical literature, and affidavits in support of her claim. ECF Nos. 14, 16, 23.

A fact hearing was held on June 8, 2017. Pre-Hearing Scheduling Order, ECF No. 25. After the hearing, petitioner was ordered to file additional medical records. Scheduling Order, ECF No. 27. Petitioner’s medical records were filed on September 8, 2017, and October 12, 2017. ECF Nos. 30, 32. This matter is now ripe for ruling.

3 The varicella zoster, or “shingles” vaccine is not covered by the Vaccine Program. See 42 C.F.R. § 100.3(a); see also Scanlon v. Sec’y of Health & Human Servs., No. 13-219V, 2013 WL 5755061 (Fed. Cl. Spec. Mstr. Sept. 27, 2013), mot. for rev. denied, 114 Fed. Cl. 135 (2013).

2 II. The Factual Record

A. Petitioner’s Pre-Vaccination Medical History

Petitioner was born on July 16, 1948. On September 13, 2013, she was 66 years old. Petitioner’s past medical history includes bilateral knee replacements in 2000, lower back laminectomy and fusion in 2002, umbilical hernia repair in 2009, left knee revision in 2011, and left hip replacement in 2012, as well as gastric band surgery and hammertoe surgery. She has degenerative joint disease and arthritis. Petitioner has used a cane in her right hand for balance and gait disturbance since her lower back surgery in 2002. She has taken hydrocodone4 for pain for several years. Pet. Ex. 1 at 2, 6; Pet. Ex. 9 at 4-12; Pet. Ex. 10 at 14; Pet. Ex. 26 at 11-20, 26; Pet. Ex. 28 at 6, 24.

Dr. Kazmar was petitioner’s primary care physician from 1998 until his retirement in or around August 2014. Tr. 86. Petitioner’s use of a cane in her right hand due to instability and balance issues since 2002 was documented throughout the record, as was her use of hydrocodone for pain. See Pet. Ex. 9 at 4, 7; Pet. Ex. 23 at 3-6; Pet. Ex. 26 at 7, 10-13, 22, 25, 26, 33, 36; Pet. Ex. 28 at 8, 12; Pet. Ex. 32 at 11, 13, 19. In addition to office visits, Dr. Kazmar’s records reflect notes for phone calls to and from petitioner for test results and/or medication renewals.5

On June 11, 2012, petitioner presented to Dr. Kazmar post hip surgery. She used a cane for balance and was noted as having “orthostasis symptoms.”6 Pet. Ex. 23 at 4.

Petitioner next visited Dr. Kazmar on October 10, 2012, for various health issues, including osteoarthritis with left groin pain, osteoarthritis with limited range of motion of her cervical spine, and pain in her left total knee arthroplasty. She was using a cane for balance. Dr.

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